Drugs & medicalClass II

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.…

Read the official notice →
Date
2022-04-27
Country
United States
Brand
Siemens Medical Solutions
Product
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM…
Classification
Class II
Units
Nationwide
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2022-05-04
  2. US
    Drugs & medicalClass II

    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 →
  3. 2022-04-27
  4. US
    Drugs & medicalClass II

    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…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    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…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide.Official notice →
  6. 2022-04-13
  7. US
    Drugs & medicalClass II

    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 →
  8. US
    Drugs & medicalClass II

    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 →
  9. 2022-04-06
  10. US
    Drugs & medicalClass II

    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…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide.Official notice →
All 70 Siemens Medical Solutions recalls →

Other drugs & medical recalls in the United States

  1. 2022-04-27
  2. US
    Drugs & medicalClass II

    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…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide.Official notice →
  3. US
    Drugs & medicalClass II

    St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER3700 programmer Model MER3400 software

    Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices,…

    FDA · DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionWorldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →
  4. US
    Drugs & medicalClass II

    SIGHT DIAGNOSTICS LTD recalls The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image…

    In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier…

    FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA,…Official notice →
  5. US
    Drugs & medicalClass II

    Medtronic Xomed, Inc. recalls Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number…

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between…

    FDA · DeviceMedtronic Xomed, Inc.International distribution country of Japan.Official notice →
  6. US
    Drugs & medicalClass II

    Huntleigh Healthcare Ltd. recalls HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

    Faceplate may become detached from the probe body.

    FDA · DeviceHuntleigh Healthcare Ltd.US Nationwide distribution in the states of OK, CA, GA, MI, VA.Official notice →
  7. US
    Drugs & medicalClass II

    Acumed LLC recalls 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

    Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture,…

    FDA · DeviceAcumed LLCWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →
See all drugs & medical recalls →