The Recall Desk
HighFDA (Devices)·Z-0563-2016·Announced 2016-01-06

Trumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard

Trumpf Medical Systems is recalling 20,713 ceiling-mounted surgical light systems because the spring arm can detach, causing the light head to fall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling heavy equipment) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm risks.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling 20,713 units of the Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5. The recall covers specific model codes including 4028110, 4028210, 4028310, 4038110, 4038210, 4038310, 1565068, 1565160, 1565161, 1574759, 1574850, and 1574851.

The recall was initiated after the firm received 15 complaints over ten years regarding the connection of the spring arm to the top horizontal arm. These reports indicated that while positioning the light head, the spring arm and light head could fall. The affected units were distributed nationwide in the United States and internationally to Canada.

Healthcare facilities and users should contact Trumpf Medical Systems, Inc. for instructions on how to address the defect. The source text does not specify a particular consumer action beyond the recall notification, nor does it report any injuries or illnesses resulting from the falling components.

The recalled product

Product
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Manufacturer
Trumpf Medical Systems, Inc.
Category
Medical Device — Surgical Lighting
Hazard
Affected units
20,713

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 4028110 - iLED Single
  • 4028210 - iLED duo
  • 4028310 - iLED trio/quad
  • 4038110 - TruLight single
  • 4038210 - TruLight duo
  • 4038310 - TruLight trio/quad
  • 1565068 - 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)

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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