FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
- Recall number
- Z-0128-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
- 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
- 46 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7728392. Serial numbers: 44075, 44077, 44084, 44240, 44262, 44265, 44267, 44268, 44269, 44270, 44271, 44272, 44273, 44274, 44275, 44276, 44277, 44278, 44279, 44280, 44281, 44282, 44283, 44284, 44285, 44286, 44287, 44288, 44289, 44290, 44291, 44292, 44293, 44294, 44295, 44296, 44298, 44299, 44300, 44302, 44303, 44304, 44305, 44306, 44307, and 44308.
- 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