SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140
  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:
Software update that provides software and firmware bug-fixes to improve system performance
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 AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Product Codes/Lot Numbers:

Serial Numbers: 65127 95798 73739 83277 66219 65491 65453 95738 96357 65615 73726 66467 64860 73860 65712 65304 65437 65614 65856 96305 73296 73831 83403 73840 64709 96335 73673 65639 95003 65501 96351 73778 96028 96316 83520 96288 66396 96238 96352 96324 96336 65480 96312 95768 73777 95955 73883 83399 73783 96226 96303 96047 65609 73791 73887 73071 96266 95701 74368 83537 73895 96214 95925 96347 96061 83533 74226 74297 65760 74376 65017 65516 73162 64065 65455 83524 66041 65618 73818 66066 73028 83306 65680 65734 73905 95797 65672 73886 96302 83398 73538 95717 96053 65972 95278 96326 96327 96286 95447 74200 74289 96364 95510 64140

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0742-2017

Related Recalls

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →
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During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Mar 12, 2026 Other Medical Devices View Details →