Recall Z-0077-2013 ยท FSY Light, Surgical, Ceiling Mounted
Trumpf Medical Systems, Inc.
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
| Date | Oct 18, 2012 (initiated Sep 19, 2012) |
| Status | Terminated |
| Reason | Incidents regarding fractures of the front joint of the spring arm have been reported. |
| Root cause | Device Design |
| Action | Trumpf sent an "URGENT RECALL NOTICE" dated September 19, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Confirmation of Receipt Form was attached for customers to complete and return. Contact the firm at 888-474-9359 for questions regarding this notice. |
| Quantity | 275 units |
| Distribution | Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI. |
| 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 |