GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 7

FDA device recall Z-1734-2019 · posted 2019-06-04 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Reason for recall

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

Action taken

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).

Root cause

Process control

Status

Terminated

Product code

LGX

Quantity affected

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 COLOMBI

Date initiated

2019-05-06

Date posted

2019-06-04

Date terminated

2022-07-06

Location

Wayne, NJ