The Recall Desk
HighFDA (Devices)·Z-2056-2014·Announced 2014-07-23

Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment

Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor 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 where the monitor mount may detach, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Stryker Communications is recalling 953 SHAPE Arm brackets, which are components of kit part number 0682000977. These articulating arm brackets are attached to the service head of boom systems used to support and position equipment, such as flat-panel video monitors, in operating rooms and patient care areas. The affected arms are part of Stryker Communications EDS or FLEXiS boom systems.

The recall is being conducted because there is a potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. The affected serial numbers range from 080909DB001 through 131021DB015. These serial and part 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 these numbers.

The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico), China, the Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia. Users should check their equipment for the affected serial numbers and contact Stryker Communications for further instructions.

The recalled product

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 Ar
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 →

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