Device product
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.
Z-0077-2013
Product summary
- Event
- Event 63255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 275 units
- Official record key
device-enforcement:Z-0077-2013
Official wording
Reason: Incidents regarding fractures of the front joint of the spring arm have been reported.
Code information: 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).
Distribution pattern: 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.
Derived failure modes
-
Unknown
Incidents regarding fractures of the front joint of the spring arm have been reported.