Recall Z-0655-2016
Skytron, Div. The KMW Group, Inc · initiated December 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms
Codes / lots: Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.
Reason for recall
The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.
FDA-determined cause: Device Design
Action taken
Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.
Details
- Recall number
- Z-0655-2016
- Initiated
- December 2, 2015
- Posted by FDA
- January 14, 2016
- Terminated
- July 19, 2016
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Quantity
- 286
- Distribution
- Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.
- Recalling firm
- Skytron, Div. The KMW Group, Inc, Grand Rapids, MI