Reported Jan 6, 2016 · Completed
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
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. · 1046 Legrand Blvd · Charleston, SC · 29492-7672
Is this the product you have?
- Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
- Lot codes and dates
4028110 - iLED Single4028210 - iLED duo4028310 - iLED trio/quad4038110 - TruLight single4038210 - TruLight duo4038310 - TruLight trio/quad1565068 - iLED single (TUSM)1565160 - iLED duo (TUSM)1565161 - iLED trio/quad (TUSM)1574759 - TruLight single (TUSM)1574850 - TruLight duo (TUSM)1574851 - TruLight trio/quad (TUSM)
- Amount recalled
- 20,713
Where it was sold
Why it was recalled
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
This product could cause temporary or reversible health problems — stop using it.
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