FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
- Recall number
- Z-1732-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
- Status
- Terminated
- Initiated
- 2010-04-12
- Posted
- 2010-05-28
- Terminated
- 2013-04-11
- Reason
- sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
- Root cause
- Device Design
- Action
- Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.
- Quantity
- 83 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and 7728392.
- 510(k) numbers
- ["K021021"]
- PMA numbers
- not on file
- Product code
- MQB
- 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