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Recall Observatory FDA recall evidence

Device product

SHAPE ARM, DUAL SH2, 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 0682400254 and the Arm part number in the kit is P17084 . 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-2053-2014

March 17, 2014

Class II

Product summary

Firm
Stryker Communications
Event
Event 67813
Status
Terminated
Classification
Class II
Quantity
953 total STRYKER SHAPE Arms of all types
Official record key
device-enforcement:Z-2053-2014

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 111018DF001 through 120409DF045 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.