Recall Z-1871-2016 ยท FQO Table, Operating-Room, Ac-Powered
Skytron, Div. The KMW Group, Inc
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
| Date | May 31, 2016 (initiated Mar 28, 2016) |
| Status | Terminated |
| 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 di |
| Quantity | 24 |
| Distribution | Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950192 | SKYTRON SKYBOOM SERIES Skytron, Div. the Kmw Group, Inc., Apr 3, 1995 |