Recall Z-1734-2019 ยท LGX Table, Examination, Medical, Powered
Maquet Cardiovascular Us Sales, Llc
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
| Date | Jun 4, 2019 (initiated May 6, 2019) |
| Status | Terminated |
| Reason | User may suffer an electric shock when coming in contact with the exposed electronic components |
| Root cause | Process control |
| Action | Maquet /Getinge issued URGENT MEDICAL DEVICE CORRECTION Notice on 5/6/19, identified issued, health risk and action to take: Per the IFU, section 8.1, a visual and functional check is required to be performed by a trained person before operation; If the plastic socket of the cold-device plug is pulled out do not try to put it back into the housing and if there are any exposed electronic components: do not touch them. Call your in-house technical service and arrange the repair of the table. Per IFU section 8.5 a defective product may not be used and may not be repaired by yourself. Complete/s |
| Quantity | U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455 |
| Distribution | Worldwide - US Nationwide Distribution Foreign: ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BOLIVIA BOTSWANA BOSNIA AND HERZEGOVINA BRAZIL BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ECUADOR EGYPT FINLAND FRANCE GABON GERMANY GREECE HONG |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.