FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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
- Recall number
- Z-2848-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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 system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
- Status
- Terminated
- Initiated
- 2020-07-14
- Posted
- 2020-08-22
- Terminated
- 2021-07-23
- Reason
- 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.
- Root cause
- Device Design
- Action
- Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to affected customers via AX013/20/S dated July 14, 2020, The letter states reason for recall, health risk and action to take: We advise urgently to cease the use of the hot plugging feature until the pending hardware update AX014/20/S has been completed. Siemens will correct the hardware error via Update Instruction AX014/20/S in which a Siemens Service Engineer will replace the main control D80. Service organization will contact you shortly to arrange a date to performthis corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice.
- Quantity
- US: 282 units; OUS: 1363
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K132094","K181550","K181560"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28