Recall Z-1569-2020— Skytron, Div. The KMW Group, Inc

Name: FDA recall Z-1569-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Class II · Ongoing

Class II FDA medical device recall by Skytron, Div. The KMW Group, Inc, initiated 2020-03-05. It names one FDA 510(k) clearance: K950192. Product: Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1. 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..

Recalling firm: Skytron, Div. The KMW Group, Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-03-05
Firm location: Grand Rapids, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K950192 — SKYTRON SKYBOOM SERIESSkytron, Div. the Kmw Group, Inc.·cleared 1995-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.