FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365.
- Recall number
- Z-0127-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365.
- 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
- 56 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7555365. Serial numbers: 57001, 57002, 57093, 57103, 57119, 57122, 57132, 57133, 57134, 57135, 57136, 57137, 57139, 57140, 57141, 57143, 57144, 57145, 57146, 57147, 57148, 57149, 57150, 57151, 57152, 57153, 57154, 57156, 57157, 57158, 57159, 57160, 57161, 57162, 571 63, 57164, 57165, 57166, 57167, 57168, 57169, 57170, 57171, 57172, 57173, 57174, 57175, 57177, 57178, 57179, 57181, 57182, 57183, 57184, 57185, and 57186
- 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