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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron Ergon 3 Series Skyboom Monitor BracketFlatscreen Bracket

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  Class 2 Device Recall Skytron Ergon 3 Series Skyboom Monitor BracketFlatscreen Bracket see related information
Date Initiated by Firm March 05, 2020
Create Date March 25, 2020
Recall Status1 Open3, Classified
Recall Number Z-1569-2020
Recall Event ID 85252
510(K)Number K950192  
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size

Part number 3FCM1
Code Information 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 
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
For Additional Information Contact SAME
616-656-2900
Manufacturer 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.
FDA Determined
Cause 2		 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 ewoolf@skytron.us 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FQO and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.
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