Recall Z-1296-2021 ยท FQO Table, Operating-Room, Ac-Powered
Getinge Group Logistics America, LLC
Operating Table System
| Date | Feb 11, 2021 |
| Status | Open, Classified |
| Reason | There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure. |
| Root cause | Device Design |
| Action | In February, 2021, Maquet GmbH/Getinge, will issue an Urgent Medical Device Correction notice to customers via FedEx 2 Day Delivery for the Magnus 1180 Operating Table due to a potential for hydraulic leakage to occur at the inclination function which may result in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning. If this were to occur, it may lead to the patient having to be transferred to another OR table causing a delay in the procedure. |
| Quantity | 4288 units |
| Distribution | Domestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colomb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.