Recall Z-0655-2016— Skytron, Div. The KMW Group, Inc
Class II · Terminated
Class II FDA medical device recall by Skytron, Div. The KMW Group, Inc, initiated 2015-12-02, terminated 2016-07-19. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-02
- Terminated
- 2016-07-19
- Firm location
- Grand Rapids, MI, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.