The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2353-2015·Announced 2015-08-19

Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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. The hazard involves a structural component (spring arm) that could break, posing a risk of harm to patients or staff, but no injuries or deaths are reported in the source text.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling 9,287 units of Trumpf Ceiling Mounted Surgical Lighting Systems, iLED 3/5. The recall is due to complaints that the front joint of the spring arm AC 2000 could break at the interface to the monitor.

The affected products are intended to locally illuminate an operating or examination area of a patient's body with high-intensity light. The recall covers units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous other countries.

Consumers and healthcare facilities should identify affected units by checking for specific material numbers listed in the recall documentation. If a unit is identified, it should be removed from service and the manufacturer contacted for instructions.

The recalled product

Product
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. 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 →

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