Recall Z-2420-2025 ยท FQO Table, Operating-Room, Ac-Powered
MAQUET GMBH
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
| Date | Aug 22, 2025 (initiated Jul 14, 2025) |
| Status | Open, Classified |
| Reason | Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel. |
| Root cause | Under Investigation by firm |
| Action | On July 21, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions Our records indicate that you have received one or more of the serial numbers that are affected by this recall. As a result, Getinge requests that you take the following actions: 1. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 2. A Getinge service techinican will contact you to set up a service visit to perform the software update. 3. Complete and return the enclose |
| Quantity | 315 units (8 US, 307 OUS) |
| Distribution | Worldwide - US Nationwide distribution in the states of KY, NY, TX and the countries of Algeria, Australia, Austria, Bulgaria, Canada, China, Colombia, Denmark, Egypt, Estonia, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Morocco, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.