Recall Z-0463-2025 ยท FQO Table, Operating-Room, Ac-Powered
Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
| Date | Nov 14, 2024 (initiated Oct 3, 2024) |
| Status | Open, Classified |
| Reason | Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay |
| Root cause | Component design/selection |
| Action | Maquet GmbH, a subsidiary of Getinge (Maquet/Getinge) issued Urgent Medical Device Correction (FSCA 8010652-09/25/2024-002-C) letter on 03 October 2024, via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the MEERA Operating Tables with the Serial numbers listed in this notice. Note: The Product REF number (REF) and the Serial Number (SN) can be found on the product label. If the error code "50037" appears-(note below picture of the remote control displaying the Error Code), it will be |
| Quantity | 1 unit |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.