Siemens Medical Solutions recalls
70 official recalls and safety alerts involving Siemens Medical Solutions since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Siemens Medical Solutions or the relevant agency.
- 2026-07-08
USSiemens Medical Solutions USA, Inc recalls ARTIS icono ceiling. Model Number: 11328100.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY,…Official notice →- US
Siemens Medical Solutions USA, Inc recalls ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-06-10
- US
Siemens Medical Solutions USA, Inc recalls ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono…
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the…
- 2026-04-22
- US
Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A, Model 10849000
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the…
- 2026-04-15
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice → - 2026-02-11
- US
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Canada, Costa…Official notice → - 2026-02-04
- US
Siemens Medical Solutions USA, Inc recalls Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version…
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY,…Official notice → - 2026-01-14
- US
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ…
- 2025-12-10
- US
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AR, CA, NY and the…Official notice → - 2025-11-19
- US
Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade. Model Number: 11689304.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting…
FDA · DeviceSiemens Medical Solutions USA, IncUS distribution to California. International distribution to Australia,…Official notice → - 2025-10-08
- US
Siemens Medical Solutions USA, Inc recalls MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515,…
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - 2025-09-17
- US
Siemens Medical Solutions USA, Inc recalls Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Limited system movements after startup .
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AL, AZ, FL, KY, MA, MI, NY, OR, A,…Official notice → - 2025-07-09
- US
Siemens Medical Solutions USA, Inc recalls interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high…
- 2025-06-25
- US
Siemens Medical Solutions USA, Inc recalls UROSKOP Omnia Max. Model Number: 10762473
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- 2025-02-05
- US
SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue…
- 2024-10-02
- US
Siemens Medical Solutions USA, Inc. recalls ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0,…
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion…
FDA · DeviceSiemens Medical Solutions USA, Inc.US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM,…Official notice → - 2024-08-14
- US
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model…
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
- 2024-07-31
- US
Siemens Medical Solutions USA, Inc recalls Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a…
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ,…Official notice → - 2024-07-03
- US
Siemens Medical Solutions USA, Inc recalls AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as…
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- 2024-05-01
- US
Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature,…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide including in the states of AL, AR, CA,…Official notice → - 2024-04-24
- US
Siemens Medical Solutions USA, Inc recalls Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137…
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break .…
- 2024-01-17
- US
Siemens Medical Solutions USA, Inc recalls Sensis Vibe Hemo
The possibility of the Sensis documentation functionality application to crash.
- 2023-12-20
- US
Siemens Medical Solutions USA, Inc recalls ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL…Official notice → - 2023-11-22
- US
Siemens Medical Solutions USA, Inc recalls Mobilett Mira wireless (VA20) mobile x-ray system(s)
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual…
- 2023-11-08
- US
Siemens Medical Solutions USA, Inc recalls ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and…
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
- 2023-10-11
- US
Siemens Medical Solutions USA, Inc recalls (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica…
In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential…
- 2023-09-20
- US
Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide - US Nationwide distribution including in the states of IL, WI, CA,…Official notice → - 2023-08-16
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material…
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - 2023-08-09
- US
Siemens Medical Solutions USA, Inc. recalls The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor…
During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the…
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution was made to ID, KS, MA, NH, OH, TX, and VA. There was no…Official notice → - 2023-08-02
- US
Siemens Medical Solutions USA, Inc recalls Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care…
Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of FL, GA, KS, MN, NC, NY…Official notice → - 2023-05-31
- US
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max (VE10, VF10, VF11)
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point,…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide - Worldwide DistributionOfficial notice → - 2023-05-10
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single…
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice → - 2023-05-03
- US
Siemens Medical Solutions USA, Inc recalls ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. Material…
Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of FL, SD, PR and the…Official notice → - 2023-04-05
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #…
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
- 2023-03-01
- US
Siemens Medical Solutions USA, Inc recalls Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model…
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
- 2023-02-22
- US
Siemens Medical Solutions USA, Inc. recalls SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R…
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide and the countries of Japan, Chile,…Official notice → - 2023-02-08
- US
Siemens Medical Solutions USA, Inc recalls System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane…
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice → - 2023-02-01
- US
Siemens Medical Solutions USA, Inc recalls Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the…
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
- 2023-01-25
- US
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical…
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Mechanical connection between the tabletop and table base may be lost.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Armenia,…Official notice → - 2023-01-11
- US
Siemens Medical Solutions USA, Inc recalls Programmable Diagnostic Computer
The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during…
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Worldwide foreign distribution to Albania…Official notice → - 2022-12-21
- US
Siemens Medical Solutions USA, Inc recalls ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use:…
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.Official notice → - 2022-11-02
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution worldwide.Official notice → - 2022-09-07
- US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide Distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice → - 2022-08-24
- US
Siemens Medical Solutions USA, Inc recalls AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo…
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia…Official notice → - 2022-07-27
- US
Siemens Medical Solutions USA, Inc recalls Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or…
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide Distribution AZ FL KY MI OH PR TXOfficial notice → - 2022-07-13
- US
Siemens Medical Solutions USA, Inc recalls Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:…
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in…
- 2022-07-06
- US
Siemens Medical Solutions USA, Inc recalls Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This…
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice → - 2022-06-15
- US
Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…
- US
Siemens Medical Solutions USA, Inc recalls Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502…
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…
- 2022-05-04
- US
Siemens Medical Solutions USA, Inc. recalls Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Transducers (component of ultrasound system) may exceed recommended thermal index limits
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice → - US
Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via…
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2022-04-27
- US
Siemens Medical Solutions USA, Inc recalls Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and…
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block…
- US
Siemens Medical Solutions USA, Inc recalls Artis zee floor MN, Model Number 10094142
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a…
- US
Siemens Medical Solutions USA, Inc recalls SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628…
Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional workflows.…
- 2022-04-13
- US
Siemens Medical Solutions USA, Inc. recalls Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
FDA · DeviceSiemens Medical Solutions USA, Inc.Distribution OUS only to El Salvador, France, Germany, Japan, Taiwan, and UK.Official notice → - US
Siemens Medical Solutions USA, Inc recalls YSIO X.Pree
For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide, Worldwide distributionOfficial notice → - 2022-04-06
- US
Siemens Medical Solutions USA, Inc recalls Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If…
- 2022-03-23
- US
Siemens Medical Solutions USA, Inc. recalls Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system…
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study…
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra,…Official notice → - 2022-02-09
- US
Siemens Medical Solutions USA, Inc. recalls ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-02-02
- US
Siemens Medical Solutions USA, Inc recalls Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be…
- 2022-01-26
- US
Siemens Medical Solutions USA, Inc recalls 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis…
Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain…
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of AK, AL, AR, AZ, CA, FL, GU, HI,…Official notice → - 2022-01-19
- US
Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus-Computed tomography system Model 1026700
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
- 2022-01-05
- US
Siemens Medical Solutions USA, Inc recalls ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic…
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA,…Official notice → - 2021-12-01
- US
Siemens Medical Solutions USA, Inc recalls Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and…
If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
- US
Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient…
- 2021-11-24
- US
Siemens Medical Solutions USA, Inc recalls Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641…
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances,…
- 2021-11-10
- US
Siemens Medical Solutions USA, Inc recalls Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system…
Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown…