Recall Z-0036-2024 ยท FQO Table, Operating-Room, Ac-Powered
Getinge Usa Sales Inc
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
| Date | Oct 4, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Maquet GMBH / Getinge initiated Urgent Medical Device Correction letter on 9/6/23 via Fed'X. 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 Mobile Operating Table with the serial numbers listed in this notice. Maintain awareness on this notice and related actions until your operating table has been updated to ensure effectiveness of the corrective action. Please complete and sign the attached MEDICAL DEVICE CORRECTION- RESPONSE FORM (page 4) to acknowledge that you have received this notificat |
| Quantity | 224 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.