Recall Z-2238-2011 ยท KXJ Table, Radiologic
Maquet Inc.
Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
| Date | May 23, 2011 (initiated Apr 15, 2011) |
| Status | Terminated |
| Reason | Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops. |
| Root cause | Device Design |
| Action | Maquet sent an Urgent Medical Device Corrective Action letter dated 4/15/2011, along with a Action Response Form, via Federal Express to their three customers informing them the incorrect cover sheets were installed with some of the affected "MAGNUS 1180.16F0 carbon-fibre table tops." The firm will have a Service Technician contact you to service the OR table, and will be exchanging the cover sheet free of charge. To the customers, please follow the instructions on the response form. At this time there have been no reports that injury has occurred. If you have additional questions, ple |
| Quantity | 3 |
| Distribution | LA, MO, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.