Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
- Company
- Trumpf Medical Systems, Inc.
- Recall Initiated
- February 19, 2013
- Posted
- December 12, 2013
- Terminated
- March 6, 2017
- Recall Number
- Z-0484-2014
- Quantity
- 287
- Firm Location
- Charleston, SC
Reason for Recall
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Distribution
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Lot / Code Info
Unknown
Root Cause
Nonconforming Material/Component
Action Taken
TRUMPF sent an Urgent Recall Notice dated February 19, 2013, to all US affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The recall notice instructed customers to verify if they still have these light systems, and if they do have the light system verify if they have a metal or plastic ring at the joint of concern (per the manufacturer's Safety Notice). TRUMPF will directly work with affected customers to replace the affected arm system. For further questions please call ( 888 ) 474-9359.