Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems
Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms 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 in a clinical setting) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Communications is recalling 953 SHAPE Arm brackets, which are articulating arm components used in boom systems to support and position equipment in operating rooms and patient care areas. The product is distributed worldwide, including in the United States, Puerto Rico, China, the Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia.
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. The affected arms are part of kit part number 0682000976, with the Arm part number P17087. These arms are used with Stryker Communications EDS or FLEXiS boom systems.
Healthcare facilities should check their inventory for SHAPE Arms with serial numbers ranging from 080924DC001 through 120227DC025. The 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. Affected units should be removed from service and returned to Stryker Communications for inspection or replacement.
The recalled product
- Product
- BAM (SHAPE) ARM, LEFT, 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 0682000976, and the Arm…
- 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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