FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
- Recall number
- Z-0124-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
- 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
- 93 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Model number 7555357. Serial numbers: 53002, 53007, 53008, 53027, 53028, 53030, 53031, 53032, 53046, 53059, 53079, 53089, 53090, 53091, 53092, 53105, 53106, 53112, 53122, 53125, 53127, 53129, 53134, 53137, 53148, 53151, 53157, 53158, 53163, 53167, 53168, 53169, 53170, 53180, 53182, 53183, 53184, 53185, 53187, 53188, 53189, 53190, 53191, 53192, 53193, 53195, 53196, 53197, 53199, 53200, 53201, 53202, 53203, 53204, 53205, 53206, 53207, 53208, 53209, 53210, 53211, 53212, 53213, 53215, 53216, 53217, 53218, 53219, 53220, 53221, 53222, 53223, 53224, 53225, 53226, 53227, 53228, 53229, 53231, 53232, 53233, 53234, 53235, 53237, 53238, 53239, 53240, 53706, 53707, 53708, 53709, 53710, and 53711.
- 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