FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717.
- Recall number
- Z-0125-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717.
- Status
- Terminated
- Initiated
- 2008-09-02
- Posted
- 2008-11-25
- Terminated
- 2009-10-05
- Reason
- Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Root cause
- Software design
- Action
- Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.
- Quantity
- 11 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7727717. Serial numbers: 40000, 40061, 40062, 40063, 40064, 40065, 40066, 40067, 40069, 40070, and 40071
- 510(k) numbers
- ["K010721","K021021"]
- 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