FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
- Recall number
- Z-1449-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
- Status
- Terminated
- Initiated
- 2004-08-10
- Posted
- 2004-09-14
- Terminated
- 2005-01-25
- Reason
- Opacification Function of device may incorrectly merge images
- Root cause
- Other
- Action
- The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem.
- Quantity
- 37 units
- Distribution
- The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.
- Lot, serial or model codes
- Serial numbers: 14002-14004, 14006-14012, 14014, 14018, 14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049, 14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071, 14074-14075, 14080-14081, 14084-14088, and 14092
- 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