FDA Device

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.

Hazard

User may suffer an electric shock when coming in contact with the exposed electronic components

What You Should Do

Remedy

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/sign and return the MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM. Questions contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. Expanded Recall: Maquet/Getinge issued letters on 9/24/20 to consignees via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD).

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Products

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 Mob
Brand
Maquet Cardiovascular Us Sales, Llc
UPC
(1) Part 720001B2 S/N 1 to S/N 416 (2) Part 720001B0 S/N 1 to S/N 1416 (3) Part 720001F2 S/N 1 to S/N 91 (4) Part 720001F0 S/N 1 to S/N 220 (5) Part 710001B2 S/N 1 to S/N 8 (6) Part 710001B0 S//N 1 to S/N 11 (7) Part 710001F0 S/N 1  Expanded lots: 720001B2 SN 417 to SN 503 720001B0 SN 1417 to SN 1689 720001F2 SN 92 to SN 119 720001F0 SN 221 to SN 226 and SN 701 to 711 710001B2 SN 9 to SN 14 710001B0 SN 12 to SN 88

Units Affected

U.S: 163; Foreign: 1864. Expanded: US:27 Foreign: 455

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