Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1

FDA device recall Z-0389-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Maquet Inc.

Reason for recall

A component of the Magnus hybrid OR system fails to respond to a position command.

Action taken

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 released and then completely secured when returned to "0" pivot position. Customers were instructed to ensure that all user of the affected product and other necessary persons are informed of the product correction notice. For technical support or questions call 1-888-627-8383

Root cause

Device Design

Status

Terminated

Product code

LFQO

Quantity affected

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.

Date initiated

2011-09-19

Date posted

2012-01-11

Date terminated

2011-12-08

Location

Wayne, NJ