Recall Z-1045-2016— Maquet Cardiovascular Us Sales, Llc

Class II FDA medical device recall by Maquet Cardiovascular Us Sales, Llc, initiated 2016-01-07, terminated 2017-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.. Reason: MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, causing it to fall down..

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Classification

Class II

Status

Terminated

Initiated

2016-01-07

Terminated

2017-05-25

Firm location

Wayne, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.