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…
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- Siemens Medical Solutions
- Product
- ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic…
- Classification
- Class II
- Units
- US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Siemens Medical Solutions recalls
- 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…
- 2024-08-14
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
Other drugs & medical recalls in the United States
- 2024-10-02
US
Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break…
FDA · DeviceWaldemar Link GmbH & Co. KG (Corp. Hq.)US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Official notice →US
American Contract Systems, Inc. recalls Pacemaker, COPM11B; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of MO, MN, MA, OH, NE.Official notice →US
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →US
GE Healthcare recalls GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a…
US
Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
US
Stryker Spine recalls AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion…
Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
FDA · DeviceStryker SpineWorldwide distribution - US Nationwide and the country of Canada.Official notice →