syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammography images.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
- 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:
- Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammography images.
Product Codes/Lot Numbers:
Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
Distribution:
Distributed in: US, PA, OH, UT, CA, NY, MO, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1859-2013
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