Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
FDA device recall Z-1449-04 · posted 2004-09-14 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Opacification Function of device may incorrectly merge images
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 37 units
- Distribution
- The product was shipped to 64 medical facilities nationwide and 2 government accounts in CA and PA.
- Date initiated
- 2004-08-10
- Date posted
- 2004-09-14
- Date terminated
- 2005-01-25
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |