FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Artis FA, Model Number 5904441
- Recall number
- Z-2013-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Artis FA, Model Number 5904441
- Status
- Terminated
- Initiated
- 2019-06-12
- Posted
- not on file
- Terminated
- 2020-09-18
- Reason
- A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
- Root cause
- Component design/selection
- Action
- Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated and any recurrence of this potential fault is prevented.
- Quantity
- 4
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 25328 25349 25382 25403
- 510(k) numbers
- ["K052202"]
- 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