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.
This recall has been terminated (originally issued July 15, 2014).
- Company
- Stryker Communications
- Recall Initiated
- March 17, 2014
- Posted
- July 15, 2014
- Terminated
- May 15, 2015
- Recall Number
- Z-2052-2014
- Quantity
- 953 STRYKER SHAPE ARMS of all types
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
Lot / Code Info
Serial numbers 111018DE001 through 140210DE020 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.
Root Cause
Process control
Action Taken
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 in the attached component/equipment falling." Stryker Communications' foreign distributors will oversee notification, inspection, and corrections of their accounts and report corrections and other findings to Stryker Communications.