Medical Device
Manufacturing
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Z-1569-2020Class II

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

Skytron, LLC / initiated 2020-03-05 / Open, Classified / root cause: design

Skytron, Div. The KMW Group, Inc began a recall of Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1 on . 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 , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1569-2020
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Skytron, LLC
Product
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
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
design
FDA 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) 768-4411 Please contact Erin Woolf, at 616-656-2998 or [email protected] with any questions. For after-hours support, please call 1-800-SKYTRON.
Quantity in commerce
43 units
Distribution
AZ, CO, GA, IL, MI, MN, NJ, PA, VA, VT
Product codes and lots
Serial Numbers: 1507T719-00-0-0087 1509T719-00-0-0142 1509T719-00-0-0144 1509T719-00-0-0139 1507T719-00-0-0085 1509T719-00-0-0135 1508T719-00-0-0115 1508T719-00-0-0116 1508T719-00-0-0119 1508T719-00-0-0120 1507T719-00-0-0074 1508T719-00-0-0129 1508T719-00-0-0121 1508T719-00-0-0123 1508T719-00-0-0124 1508T719-00-0-0125 1508T719-00-0-0126 1509T719-00-0-0132 1509T719-00-0-0146 1507T719-00-0-0103 1507T719-00-0-0104 1507T719-00-0-0053 1507T719-00-0-0054 1507T719-00-0-0055 1507T719-00-0-0056 1507T719-00-0-0058 1507T719-00-0-0059 1507T719-00-0-0061 1507T719-00-0-0062 1507T719-00-0-0063 1507T719-00-0-0064 1508T719-00-0-0127 1508T719-00-0-0128 1510T719-00-0-0153 1510T719-00-0-0154 1510T719-00-0-0157 1510T719-00-0-0160 1510T719-00-0-0166 1508T719-00-0-0118 1510T719-00-0-0159 1508T719-00-0-0114 1508T719-00-0-0117 1508T719-00-0-0122

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1569-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1569-2020Class IIOngoingVoluntary: Firm initiated