Z-0655-2016Class II

Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in...

Name: Z-0655-2016 Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in...
Creator: Skytron, Div. The KMW Group, Inc
Published: 2015-12-02
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2015-12-02 / Terminated / root cause: design

FDA source

Skytron, Div. The KMW Group, Inc began a recall of Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to... on 2015-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0655-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-02
Posted: 2016-01-14
Terminated: 2016-07-19
Recalling firm: Skytron, LLC
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
Product code: FQO Table, Operating-Room, Ac-Powered
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0655-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0655-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-14

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)