FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis X-Ray System using software version VB11D or VB20B
- Recall number
- Z-0796-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis X-Ray System using software version VB11D or VB20B
- Status
- Terminated
- Initiated
- 2005-04-11
- Posted
- 2005-05-03
- Terminated
- 2006-08-23
- Reason
- Live display in exam room may sporadically stop working although the display in the control room remains fully operational
- Root cause
- Other
- Action
- The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.
- Quantity
- 295 units
- Distribution
- The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
- Lot, serial or model codes
- model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350
- 510(k) numbers
- ["K010721"]
- PMA numbers
- not on file
- Product code
- IZI
- 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