Recall Z-0389-2012 ยท LFQ Acid, Uric, Acid Reduction Of Ferric Ion
Maquet Inc.
Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
| Date | Jan 11, 2012 (initiated Sep 19, 2011) |
| Status | Terminated |
| Reason | A component of the Magnus hybrid OR system fails to respond to a position command. |
| Root cause | Device Design |
| Action | Maquet sent a PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION letter dated September 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. To avoid the potential of a malfunction occurring prior to their scheduled Service procedure, customers were instructed to ensure that the MAGNUS table-top is positioned at the "0" pivot position and that the MAGNUS column pivot brake is secured. If it is necessary to pivot the MAGNUS table-top prior to procedure start, ensure that the column pivot brake is completely releas |
| Quantity | 45 UNITS |
| Distribution | Worldwide Distribution - USA including VA, LA, MO, NC, MD, and AZ and the countries of AE, AU, CA, CH, CN, DE, DK, ES, IE, IL, SP, PL, RU, and TH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.