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.
- Company
- Trumpf Medical Systems, Inc.
- Recall Initiated
- September 19, 2012
- Posted
- October 18, 2012
- Terminated
- January 21, 2014
- Recall Number
- Z-0077-2013
- Quantity
- 275 units
- Firm Location
- Charleston, SC
Reason for Recall
Incidents regarding fractures of the front joint of the spring arm have been reported.
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.
Lot / Code Info
Ondal AC2000 serial range of the spring arms requiring rework: 0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number).
Root Cause
Device Design
Action Taken
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.