Reported Oct 24, 2012 · Terminated
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an…
Trumpf Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trumpf Medical Systems, Inc. · 415 Jessen Ln · Charleston, SC · 29492
Is this the product you have?
- 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.
- Lot codes and dates
- Ondal AC2000 serial range
- of the spring arms requiring rework0111 010 xxxxxx to 0111 066 xxxxx (010 to 066 = month 01/year 20000 to month 06/year 2006 xxxxxx = 5 digit serial number)
- Amount recalled
- 275 units
Where it was sold
Why it was recalled
Incidents regarding fractures of the front joint of the spring arm have been reported.
This product could cause temporary or reversible health problems — stop using it.
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