Axiom Iconos R200 X-Ray
FDA device recall Z-1213-2010 · posted 2010-03-27 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- table can tilt/move when it is not intended
- Action taken
- The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 169 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2010-01-29
- Date posted
- 2010-03-27
- Date terminated
- 2010-08-11
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| URF DIGITAL - OT (K992660) | Siemens Medical Solutions USA, Inc. | 1999-11-05 |