Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1
FDA Recall Z-0389-2012 · Posted 2012-01-11
Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeLFQO
Date Initiated2011-09-19
Date Terminated2011-12-08
Product Quantity45 UNITS
Reason for Recall
A component of the Magnus hybrid OR system fails to respond to a position command.
Firm 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 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.
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Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.