Device product
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 attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Z-2054-2014
Product summary
- Event
- Event 67813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 953 TOTAL SHAPE Arms of all types
- Official record key
device-enforcement:Z-2054-2014
Official wording
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.
Code information: Serial numbers 111108DD001 through 131115DD020 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.
Distribution pattern: Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia
Derived failure modes
-
Unknown
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.