Class 2 Device Recall Ergon III Series Skyboom Monitor Bracket

• Date Initiated by Firm: March 28, 2016
• Date Posted: May 31, 2016
• Recall Status: Terminated on July 25, 2017
• Recall Number: Z-1871-2016
• Recall Event ID: 73704
• 510(K)Number: K950192
• Product Classification: Monitor support, operating-room - Product Code FQO
• Product: Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
• Code Information: Model Number(s): 3FCM1; Manufactured Date: September 2015; Serial Numbers 1507T719-00-0-0074, 1507T719-00-0-0091, 1507T719-00-0-0095, 1507T719-00-0-0096, 1507T719-00-0-0102, 1507T719-00-0-0107, 1508T719-00-0-0129, 1507T719-00-0-0087, 1507T719-00-0-0069, 1507T719-00-0-0103, 1507T719-00-0-0104, 1507T719-00-0-0066, 1507T719-00-0-0072, 1507T719-00-0-0073, 1507T719-00-0-0075, 1507T719-00-0-0088, 1507T719-00-0-0101, 1507T719-00-0-0108, 1507T719-00-0-0112, 1507T719-00-0-0113, 1507T719-00-0-0090, 1507T719-00-0-0097, 1507T719-00-0-0099, and 1507T719-00-0-0100
• 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; 616-656-6403
• 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: Process design
• Action: Skytron LLC initiated a voluntary recall of twenty-four monitor brackets used as a 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 3 equipment pendant /booms via telephone calls to customers, and written notices sent via certified USPS mail on 04/01/2016. All potentially affected users will receive a field correction notification directly from Skytron, LLC along with the contact information of their local Skytron distributor. Skytron distributors must contact identified users within the universe of affected products to schedule a time replace the affected monitor bracket(s). Skytron will provide a replacement of the monitor bracket. The replacement monitor bracket(s) and installation must be conducted by you, the Skytron distributor. The affected monitor bracket(s) and Service Report indicating that the monitor bracket(s) was replaced must be returned to Skytron. Please contact Larry Perez, Vice President of Technical Services, at 616-656-1187 or lperez@skytron.us, or Thao Selleck, Complaint Resolution Analyst, at 616-656-6403 or tselleck@skytron.us with any questions. For after-hours support, please call 1-800-SKYTRON.
• Quantity in Commerce: 24
• Distribution: Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; 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.

• 510(K) Database: 510(K)s with Product Code = FQO and Original Applicant = SKYTRON, DIV. THE KMW GROUP, INC.