Agency classClass IIOur severity:High FDA (Devices)·Z-2053-2014·Announced 2014-07-23

Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment

Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 equipment) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker Communications is recalling the SHAPE Arm, Dual SH2, an articulating arm bracket used to support and position equipment in operating rooms and patient care areas. The product is a component of kit part number 0682400254, with the Arm part number P17084. The kit supports a flat-panel video monitor attached to Stryker Communications boom systems, specifically the EDS or FLEXiS types.

The recall is due to a potential safety hazard where the monitor mount may come off the SHAPE Arm if the lock washer and screw are not present. This defect could result in the equipment falling, posing a risk of injury to patients or staff in the operating room or patient care area.

A total of 953 Stryker SHAPE Arms of all types are affected. The products were distributed worldwide, including the United States (nationwide and Puerto Rico), China, the Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia. Affected units have serial numbers ranging from 111018DF001 through 120409DF045. 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. Users should contact Stryker Communications for instructions on how to resolve this issue.

The recalled product

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…
Manufacturer: Stryker Communications
Category: Medical Device — Operating Room Equipment
Hazard: falling-object
structural-defect
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 →

Same manufacturer · Stryker Communications

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