CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report

Helion and Xenion surgical lights, 501/01 series KLM lights recalled

Trumpf Medical Systems is recalling Helion and Xenion surgical lights, 501/01 series KLM lights, distributed nationwide in the US. The recall was initiated on 19 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOndal 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).

Quantity recalled275 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0077-2013
FDA event ID: 63255
Recalling firm: Trumpf Medical Systems, Charleston, SC
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2012
FDA classified: 18 Oct 2012
Reported: 24 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Sep 2012	Recall initiated by company
18 Oct 2012	Classified by FDA	+29 days
24 Oct 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Colorado Connecticut Florida Georgia Illinois Kansas Massachusetts Michigan Missouri North Carolina New Jersey New York Ohio South Carolina Texas Utah Vermont Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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).

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Trumpf Medical Systems

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