Recall Z-0484-2014 ยท FSY Light, Surgical, Ceiling Mounted
Trumpf Medical Systems, Inc.
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.
| Date | Dec 12, 2013 (initiated Feb 19, 2013) |
| Status | Terminated |
| Reason | Possible fatigue failure of the plastic joint may occur after an average use of seven years. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 287 |
| Distribution | US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 Trumpf Medical Systems, Inc., Jun 13, 2001 |