SOMATOM Drive with software syngo.CT VB20 Model #10431700
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- 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 rescans, and/or the need for additional contrast media may occur
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Product Codes/Lot Numbers:
Serial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0287-2022
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
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.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
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.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
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.