Z-1871-2016Class II

Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max...

Name: Z-1871-2016 Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max...
Creator: Skytron, Div. The KMW Group, Inc
Published: 2016-03-28
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2016-03-28 / Terminated / root cause: manufacturing process

FDA source

Skytron, Div. The KMW Group, Inc began a recall of Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size on 2016-03-28. FDA classified it as Class II and gives the reason as "Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1871-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-05-31
Terminated: 2017-07-25
Recalling firm: Skytron, LLC
Product: Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Skytron LLC initiated a voluntary recall of twenty-four monitor brackets used as a 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 3 equipment pendant /booms via telephone calls to customers, and written notices sent via certified USPS mail on 04/01/2016. All potentially affected users will receive a field correction notification directly from Skytron, LLC along with the contact information of their local Skytron distributor. Skytron distributors must contact identified users within the universe of affected products to schedule a time replace the affected monitor bracket(s). Skytron will provide a replacement of the monitor bracket. The replacement monitor bracket(s) and installation must be conducted by you, the Skytron distributor. The affected monitor bracket(s) and Service Report indicating that the monitor bracket(s) was replaced must be returned to Skytron. Please contact Larry Perez, Vice President of Technical Services, at 616-656-1187 or [email protected], or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or [email protected] with any questions. For after-hours support, please call 1-800-SKYTRON.
Quantity in commerce: 24
Distribution: Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.
Product codes and lots: Model Number(s): 3FCM1; Manufactured Date: September 2015; Serial Numbers 1507T719-00-0-0074, 1507T719-00-0-0091, 1507T719-00-0-0095, 1507T719-00-0-0096, 1507T719-00-0-0102, 1507T719-00-0-0107, 1508T719-00-0-0129, 1507T719-00-0-0087, 1507T719-00-0-0069, 1507T719-00-0-0103, 1507T719-00-0-0104, 1507T719-00-0-0066, 1507T719-00-0-0072, 1507T719-00-0-0073, 1507T719-00-0-0075, 1507T719-00-0-0088, 1507T719-00-0-0101, 1507T719-00-0-0108, 1507T719-00-0-0112, 1507T719-00-0-0113, 1507T719-00-0-0090, 1507T719-00-0-0097, 1507T719-00-0-0099, and 1507T719-00-0-0100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1871-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1871-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code FQO

K950192Class ISkytron Skyboom SeriesSkytron, Div. the Kmw Group, Inc. / cleared 1995-04-03

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)