Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357,
FDA device recall Z-1312-2010 · posted 2010-04-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Communication problems can occur which may result in unavailability of Bypass Fluoro.
- Action taken
- The recalling firm issued a Customer Safety Advisory Notice dated 2/16/10 to inform their customers of the problem. The letter identified the affected product and stated that the problem had been solved by the service technician by the time that customers would receive the letter. The letter also explained when the problem occurred and the possible risks associated with it. In addition, the firm stated what will be done to avoid the problem.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 640 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-02-16
- Date posted
- 2010-04-08
- Date terminated
- 2012-07-05
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |