Recall Z-2052-2014— Stryker Communications
Class II · Terminated
Class II FDA medical device recall by Stryker Communications, initiated 2014-03-17, terminated 2015-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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 number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.. Reason: During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present..
- Recalling firm
- Stryker Communications
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-17
- Terminated
- 2015-05-15
- Firm location
- Flower Mound, TX, United States
Product description
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 number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.
Reason for recall
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Data sourced from openFDA. This site is unofficial and independent of the FDA.