Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Compo
FDA device recall Z-1438-2009 · posted 2009-06-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Action taken
- The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 427 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-05-01
- Date posted
- 2009-06-16
- Date terminated
- 2009-09-01
- 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 |