Recall Z-1441-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281151 Surgery lamp, 115V.
| Date | Jun 16, 2009 (initiated May 1, 2009) |
| Status | Terminated |
| Reason | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
| Root cause | Other |
| Action | 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. |
| Quantity | 427 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052202 | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Mar 7, 2006 |