FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Luminos Agile
- Recall number
- Z-1001-2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Luminos Agile
- Status
- Open, Classified
- Initiated
- 2022-12-09
- Posted
- 2023-01-20
- Terminated
- not on file
- Reason
- There is potential for the footrest to detach from the patient table during use.
- Root cause
- Process control
- Action
- A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.
- Quantity
- 271 units
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)
- 510(k) numbers
- ["K111292"]
- PMA numbers
- not on file
- Product code
- JAA
- 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