Recall Z-2054-2014 · BRY Cabinet, Table And Tray, Anesthesia

Stryker Communications

SHAPE ARM, SINGLE WITH GCX MOUNT, 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 component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attach

Date	Jul 15, 2014 (initiated Mar 17, 2014)
Status	Terminated
Reason	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.
Root cause	Process control
Action	Direct accounts in the US were notified by letter dated March 21, 2014, and asked to report any malfunctions to Stryker Communications immediately. In addition, Stryker Representatives will visit all US accounts to inspect all the product units on hand. If needed, Representatives will check that black, screw/lock washers supplied by Stryker are secured in place and will replace any that are not the typed furnished by Stryker. All units will be updated with a yellow, warning sticker on the monitor bracket which reads: "Failure to properly install the screw and lock washer below can result i
Quantity	953 TOTAL SHAPE Arms of all types
Distribution	Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.