SOMATOM Definition AS, 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 - DangerousWhat Should You Do?
- Check if you have this product: Model#' 8098027 with Serial numbers 66441 95601 95610 65831 65868 95596 95600 95604 65968 66506 95043 95582 65764 95602 66146 65578 95584 66476 95578 66467 95609 66503 66475 66455 65597 65233 95599 64942 65446 66396 95474 66304 66423 66473 66473 95438 95581 66232 66173 66404 95491 66514 66321 65583 65586 66457 66490 66253 95579 66579 95593 95575 95592 66001 66407 95580 65693 66112 66470 95591 95559 66434 66230 95608 95510 66303
- 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 bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin
- 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, 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:
Model#' 8098027 with Serial numbers 66441 95601 95610 65831 65868 95596 95600 95604 65968 66506 95043 95582 65764 95602 66146 65578 95584 66476 95578 66467 95609 66503 66475 66455 65597 65233 95599 64942 65446 66396 95474 66304 66423 66473 66473 95438 95581 66232 66173 66404 95491 66514 66321 65583 65586 66457 66490 66253 95579 66579 95593 95575 95592 66001 66407 95580 65693 66112 66470 95591 95559 66434 66230 95608 95510 66303
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0021-2016
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