Stryker SHAPE Arm Recall for Potential Monitor Mount Detachment
Stryker Communications is recalling 953 SHAPE Arm components because the monitor mount may detach if a lock washer and screw are 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 monitor) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed incidents.
Plain-English summary
Stryker Communications is recalling 953 SHAPE Arm, Single components. These articulating arm brackets are used in operating rooms and patient care areas to support and position flat-panel video monitors attached to Stryker Communications boom systems (EDS or FLEXiS). The product is distributed worldwide, including the United States, Puerto Rico, and various international locations.
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 could result in the monitor falling. The affected units have serial numbers ranging from 111018DE001 through 140210DE020. 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.
Healthcare facilities and users should check their inventory for these specific serial numbers. If the lock washer and screw are not present, the monitor mount should not be used until the issue is resolved. Stryker Communications is the recalling firm.
The recalled product
- Product
- SHAPE ARM, SINGLE, 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 0682400253 and the Arm part…
- Manufacturer
- Stryker Communications
- Affected units
- 953
Distribution
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.
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