Device Recall Ergon III Series Skyboom Monitor Bracket 의 리콜

Recall

73704

Class 2

Z-1871-2016

2016-03-28

2016-05-31

Terminated

United States

2017-07-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144784

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.

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.