FDAFDA · Food and drugs·Recall number Z-0077-2013
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.
Published October 24, 2012 · Recall initiated: September 19, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incidents regarding fractures of the front joint of the spring arm have been reported.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trumpf Medical Systems, Inc.
- Distributor
- 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
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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