SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 74363 73758 73513 74368 73368 73035 73895 73297 73182 73122 74262 74116 73253 73337 73375 74158 74153 73153 73545 74192 98613 74925 73670 73361 74226 74297 74234 74364 74376 73162 73262 73328 73241 73683 74048 74068 73320 73697 73635 73405 73471 74912 73160 73600 73742 73030 73655 73931 73921 73818 73873 73028 74145 73155 73591 74904 73905 73938 98605 73244 73546 74922 73478 73547 73442 73886 73504 73413 73674 73514 73464 73445 74129 73538 73420 73904 74093 73127 73185 73268 73761 74200 74289 74062 73521 73522 73261 73357 73430 74251 73235 73911 73574 73061 73604 74152 73151 73225
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 Flash (Model 10430603) Computed tomography x-ray diagnostic system

Product Codes/Lot Numbers:

Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 74363 73758 73513 74368 73368 73035 73895 73297 73182 73122 74262 74116 73253 73337 73375 74158 74153 73153 73545 74192 98613 74925 73670 73361 74226 74297 74234 74364 74376 73162 73262 73328 73241 73683 74048 74068 73320 73697 73635 73405 73471 74912 73160 73600 73742 73030 73655 73931 73921 73818 73873 73028 74145 73155 73591 74904 73905 73938 98605 73244 73546 74922 73478 73547 73442 73886 73504 73413 73674 73514 73464 73445 74129 73538 73420 73904 74093 73127 73185 73268 73761 74200 74289 74062 73521 73522 73261 73357 73430 74251 73235 73911 73574 73061 73604 74152 73151 73225

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1747-2018

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