FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The 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-2887-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The 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
- 2020-07-30
- Posted
- not on file
- Terminated
- 2021-05-20
- Reason
- Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
- Root cause
- Device Design
- Action
- Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 27, 2020 to customers. This letter explains the issue that may arise while using the system. The letter instructs users to NOT disconnect the main unit from the monitor trolley when the system displays the system error message Err 16305 / 80: Confirm this error and repeat your last action to avoid potential electrical shock until pending hardware update has been completed. Our service organization will contact you for an appointment to perform the corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.This letter asks users to acknowledge receipt of the consignee letter by signing and returning the document. If you have any further questions, call 610-219-4834 or rebecca.tudor@siemens-healthineers.com.
- Quantity
- 329 units in total
- Distribution
- US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.
- Lot, serial or model codes
- Cios Alpha (VA20)- 10308191 Cios Alpha (VA30)- 11105200
- 510(k) numbers
- ["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