FDA Device recall Z-0655-2016
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing pu…
- FDA Device
- Class II
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class II recall of Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing pu… by Skytron Div The Kmw Group, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-02 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Skytron Div The Kmw Group |
| Distribution | AZ, CA, CO, DE, FL, HI, IA, IL, IN, MA, MD, MI, MO, MT, NC, NJ, NY, OH, OK, PA, TX, UT, WI, WV, WY |
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2016%22
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