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Recall Observatory FDA recall evidence

Device product

BAM (SHAPE) ARM, RIGHT, 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 0682000977, and the Arm part number in the kit is 01000221456. 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-2056-2014

March 17, 2014

Class II

Product summary

Firm
Stryker Communications
Event
Event 67813
Status
Terminated
Classification
Class II
Quantity
953 SHAPE Arms of all types
Official record key
device-enforcement:Z-2056-2014

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 080909DB001 through 131021DB015 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

    reason.no_named_rule · v1.0.0

    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.