The Recall Desk
HighFDA (Devices)·Z-2355-2015·Announced 2015-08-19

Trumpf Ceiling Mounted Surgical Lighting Systems Recalled Due to Spring Arm Defect

Trumpf Medical Systems is recalling 9,287 ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

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 is classified as FDA Class II, and the source text describes a mechanical defect (joint breakage) in a medical device without reporting specific injuries or hospitalizations, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling 9,287 units of its Ceiling Mounted Surgical Lighting Systems, specifically the Helion and Xenion S/M/L models. These devices are intended to locally illuminate an operating or examination area of a patient's body with high-intensity light.

The recall was initiated due to complaints that the front joint of the spring arm AC 2000 could break at the interface to the monitor. This defect poses a risk of the component failing during use. The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous other countries.

Healthcare facilities and consumers should stop using the affected surgical lighting systems and contact Trumpf Medical Systems for instructions on how to proceed with the recall. The specific material numbers associated with the recalled units are listed in the official FDA recall record Z-2355-2015.

The recalled product

Product
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Manufacturer
Trumpf Medical Systems, Inc.
Category
Medical Device — Surgical Lighting
Hazard
Affected units
9,287

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 (20)

  • Description: Federarm 3kg
  • 3 polig (Swing)
  • 0376289
  • Federarm 12-18kg
  • 5-polig Kamera eco
  • 0376290
  • Federarm TFT Stop AC 2000
  • 9-15kg
  • 0376291
  • Federarm TFT Stop AC 3000
  • 12-18kg
  • 0376292
  • Federarm TFT Stop Space bis 30kg
  • 0376293
  • Federarm 3-polig NRH
  • 0376294
  • Federarm 5-polig NRH
  • 0376295
  • Federarm 3-polig NRH gerader Abgang
  • 0376296

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Trumpf Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Trumpf Medical Systems, Inc.

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Same hazard · mechanical failure

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