Recalls / —
—#34769
Product
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
- FDA product code
- IZI — System, X-Ray, Angiographic
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K010721
- Affected lot / code info
- 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
Why it was recalled
Opacification Function of device may incorrectly merge images
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.
Timeline
- Recall initiated
- 2004-08-10
- Posted by FDA
- 2004-09-14
- Terminated
- 2005-01-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.