Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.
FDA device recall Z-0120-2009 · posted 2008-11-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 145 units
- Distribution
- Nationwide.
- Date initiated
- 2008-09-02
- Date posted
- 2008-11-25
- Date terminated
- 2009-10-05
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |
| AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |