Recall Z-0515-2013 ยท FSY Light, Surgical, Ceiling Mounted
Siemens Medical Solutions USA, Inc
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
| Date | Dec 12, 2012 (initiated Oct 10, 2012) |
| Status | Terminated |
| Reason | A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. |
| Root cause | Equipment maintenance |
| Action | Siemens sent a Customer Safety Advisory Notice on October 3, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were reminded that they should contact the service department in the event of damage or other irregularity. Customers were instructed to forward the information contained in the notice to their employees responsible for the operation of the affected product. Customers were also asked to forward the safety information to other organization affected by the product and to any users of the product. F |
| Quantity | 1315 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063333 | M3 Mavig GmbH, Nov 21, 2006 |