Stryker Communications recalls SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for

Recalled July 23, 2014 · FDA recall Z-2052-2014 · Stryker Communications

Hazard

During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. · FDA Class II

Units

953 STRYKER SHAPE ARMS of all types

Sold at

Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia

Description

During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

Product

SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

Manufacturer(s)

Stryker Communications

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →