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U.S. Department of Health and Human Services

Class 2 Device Recall Skytron Ergon 2 Skyboom

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  Class 2 Device Recall Skytron Ergon 2 Skyboom see related information
Date Initiated by Firm December 02, 2015
Date Posted January 14, 2016
Recall Status1 Terminated 3 on July 19, 2016
Recall Number Z-0655-2016
Recall Event ID 72897
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product Ergon 2 Articulating Equipment Boom Monitor Brackets

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 2 equipment pendant / booms
Code Information Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd Se
Grand Rapids MI 49512-5515
For Additional Information Contact Thao Selleck
616-656-2900
Manufacturer Reason
for Recall		 The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.
FDA Determined
Cause 2		 Device Design
Action Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.
Quantity in Commerce 286
Distribution Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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