The Recall Desk
HighFDA (Devices)·Z-2054-2014·Announced 2014-07-23

Stryker Communications Recalls SHAPE Arm Monitor Mounts

Stryker Communications is recalling SHAPE Arm monitor mounts because the mount may detach if a lock washer and screw are missing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling monitor) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker Communications is recalling the SHAPE Arm, Single with GCX Mount, an articulating arm bracket used in operating rooms and patient care areas. The product is a component of kit part number 0682400256, with the specific arm part number P17087. The arm is used to support flat-panel video monitors attached to Stryker Communications boom systems, specifically the EDS or FLEXiS types.

The recall is being conducted because there is a potential for the monitor mount to come off the SHAPE Arm if the lock washer and screw are not present. This defect could result in the monitor falling.

A total of 953 SHAPE Arms of all types are affected by this recall. The products were distributed worldwide, including the United States (nationwide including Puerto Rico), China, the Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia. Affected serial numbers range from 111108DD001 through 131115DD020. These numbers are located on the underside of the cover of the portion of the arm attached to the boom's service head; screws must be removed and the cover detached to view them.

The recalled product

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
Manufacturer
Stryker Communications
Category
Medical Device — Operating Room Equipment
Hazard
Affected units
953

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Stryker Communications under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

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