FDA Medical Device Recalls (openFDA)
Skytron, Div. The KMW Group, Inc: Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
- Recall number
- Z-1871-2016
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Product
- Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
- Status
- Terminated
- Initiated
- 2016-03-28
- Posted
- 2016-05-31
- Terminated
- 2017-07-25
- Reason
- 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
- 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 lperez@skytron.us, or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or tselleck@skytron.us with any questions. For after-hours support, please call 1-800-SKYTRON.
- Quantity
- 24
- Distribution
- Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K950192"]
- PMA numbers
- not on file
- Product code
- FQO
- Firm FEI
- 1825014
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28