Recall Z-0390-2017 ยท FQO Table, Operating-Room, Ac-Powered
Maquet Medical Systems USA
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
| Date | Oct 5, 2016 |
| Status | Terminated |
| Reason | Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail. |
| Root cause | Nonconforming Material/Component |
| Action | Maquet Medical Systems USA sent an Urgent Product Recall Medical Device Removal letter dated October 5, 2016 to the affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Read this Medical Device Removal Notice and disseminate the information provided to all the users of the device. 2. Examine your inventory immediately to determine if you have the Accessory Adapter(s). If so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet. 3. Please fill out and sign the |
| Quantity | 9 Units (US) 141 Units (OUS) |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.