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Recall Observatory FDA recall evidence

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

September 19, 2012

Class II

Product summary

Firm
Trumpf Medical Systems, Inc.
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

    reason.no_named_rule · v1.0.0

    Incidents regarding fractures of the front joint of the spring arm have been reported.