Recall Z-1569-2020 ยท FQO Table, Operating-Room, Ac-Powered
Skytron, Div. The KMW Group, Inc
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
| Date | Mar 5, 2020 |
| Status | Open, Classified |
| 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 | Device Design |
| Action | Skytron customer notification letters mailed on 3/5/2020. Distributors received notification via email on 3/5/2020. Letter states reason for recall, health risk and action to take: 1.Identify and inspect your 3FCM1 monitor bracket(s). 1508T719-00-0-0120 2.Remove from service any bracket with noticeable physical distortion or cracking around the welded area. 3.Skytron authorized representatives have been directed to contact and schedule a service visit within a 30-day window of time. The contact information for your authorized representative is: Johnsons Medical, Inc. Donna Johnson, (801) 7 |
| Quantity | 43 units |
| Distribution | AZ, CO, GA, IL, MI, MN, NJ, PA, VA, VT |
| 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 |