Cios Alpha recall
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…
Why was Cios Alpha recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- US: 282 units; OUS: 1363
- Distribution
- Nationwide
- Recall date
- September 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)