Recalls / —
—#34770
Product
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656
- 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: 28000, and 28002-28118
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 #34770. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.