SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers:83249 83277 83632 83336 83401 83204 83562 83564 83582 83390 83088 83234 83235 83645 83321 83527 83332 83026 83281 83558 83546 83339 83244 83585 83613 83226 83330 83214 83271 83607 83403 83599 83246 83388 83021 83584 83591 83574 83210 83552 83541 83020 83626 83308 83375 83227 83359 83031 83520 83262 83557 83081 83292 83090 83544 83083 83096 83294 83319 83581 83056 83041 83363 83307 83236 83348 83567 83378 83399 83258 83084 83004 83237 83205 83014 83573 83233 83352 83569 83537 83355 83395 83621 83335 83278 83322 83392 83622 83276 83279 83327 83091 83371 83533 83597 83034 83059 83230 83254 83267 83055 83291 83046 83524 83044 83243 83637 83640 83232 83362 83306 83542 83257 83539 83094 83239 83398 83565 83313 83653 83347 83349 83323 83324 83618 83266 83387 83516 83627 83095 83042 83611 83633 83589
- 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:
- There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Product Codes/Lot Numbers:
Serial Numbers:83249 83277 83632 83336 83401 83204 83562 83564 83582 83390 83088 83234 83235 83645 83321 83527 83332 83026 83281 83558 83546 83339 83244 83585 83613 83226 83330 83214 83271 83607 83403 83599 83246 83388 83021 83584 83591 83574 83210 83552 83541 83020 83626 83308 83375 83227 83359 83031 83520 83262 83557 83081 83292 83090 83544 83083 83096 83294 83319 83581 83056 83041 83363 83307 83236 83348 83567 83378 83399 83258 83084 83004 83237 83205 83014 83573 83233 83352 83569 83537 83355 83395 83621 83335 83278 83322 83392 83622 83276 83279 83327 83091 83371 83533 83597 83034 83059 83230 83254 83267 83055 83291 83046 83524 83044 83243 83637 83640 83232 83362 83306 83542 83257 83539 83094 83239 83398 83565 83313 83653 83347 83349 83323 83324 83618 83266 83387 83516 83627 83095 83042 83611 83633 83589
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1746-2018
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.