Recall Z-1045-2016 ยท FQO Table, Operating-Room, Ac-Powered
Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
| Date | Mar 3, 2016 (initiated Jan 7, 2016) |
| Status | Terminated |
| Reason | MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down. |
| Root cause | Under Investigation by firm |
| Action | Maquet sent "URGENT PRODUCT RECALL MEDICAL DEVICE CORRECTION" letters/MEDICAL DEVICE CORRECTION RESPONSE FORM dated January 7, 2016, via UPS to the affected customers. The notification informed customers of the issue with the affected product; how to identify affected product; measures to be taken by the users; and that a MAQUET service representative will be contacting them to schedule servicing of the device to install a Support Frame Lock. Customers with questions were asked to contact their local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Option 2, Option 3) |
| Quantity | 2 within US; 247 OUS |
| Distribution | Worldwide Distribution - US including AZ and MO. Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.