Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point… — Class II medical device recall Z-0655-2016
Terminated recall by Skytron, Div. The KMW Group, Inc, reported 2016-01-20, distributed in AZ, CA, CO, DE, FL, HI, IA, IL…. The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the
| Recall number | Z-0655-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, United States |
| Recall initiated | 2015-12-02 |
| Classified | 2016-01-14 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-07-19 |
| Distributed | 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 |
| Countries outside the US | CA, JP |
| Quantity | 286 |
| Reason classes | device malfunction |
| Model numbers | H8-010-50-FC2-LH, H8-010-50-FC2-RH |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0655-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.