Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Class I - DangerousWhat Should You Do?
- Check if you have this product: S-N Affected systems: 10xxx: 10001; 10003; 10010 10027; 10029 10031; 10033 10040; 10042 10045; 10048 10052; 10054 10110; 10112 10119 11xxx: 11000 11004; 11006 11028; 11030 11101; 11103 11183; 11185 11205; 11207 11372; 11374 11387; 11600 11608 12xxx: 12000 12014; 12016 12024; 12026 12045; 12047 12052; 12054; 12200 12207; 12301 12493; 12495 12505; 12507 12522; 12524 12550; 12552 12571; 12573; 12575 12610; 12612 12746; 12800 12803; 12805 12811; 12813 12889; 12891 12959; 12961 12973; 12975 12999 13xxx: 13000 13085; 13087; 13088; 13092; 13103 13105; 13114; 13121 4xxxx: 416; 40000; 40001; 40003 40021; 40030; 40038; 40070 5xxxx: 50001 50053; 50055; 50075 Expanded Recall: 11143, 12490
- 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:
- Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Product Codes/Lot Numbers:
S-N Affected systems: 10xxx: 10001; 10003; 10010 10027; 10029 10031; 10033 10040; 10042 10045; 10048 10052; 10054 10110; 10112 10119 11xxx: 11000 11004; 11006 11028; 11030 11101; 11103 11183; 11185 11205; 11207 11372; 11374 11387; 11600 11608 12xxx: 12000 12014; 12016 12024; 12026 12045; 12047 12052; 12054; 12200 12207; 12301 12493; 12495 12505; 12507 12522; 12524 12550; 12552 12571; 12573; 12575 12610; 12612 12746; 12800 12803; 12805 12811; 12813 12889; 12891 12959; 12961 12973; 12975 12999 13xxx: 13000 13085; 13087; 13088; 13092; 13103 13105; 13114; 13121 4xxxx: 416; 40000; 40001; 40003 40021; 40030; 40038; 40070 5xxxx: 50001 50053; 50055; 50075 Expanded Recall: 11143, 12490
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2848-2020
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