Reported Aug 19, 2015 · Terminated

Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights…

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?

  • Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
Lot codes and dates
  • The following Material numbers may appear on any of
  • the attached recalled/corrected unitsMaterial #0376288
  • Description

    272 of 272 codes

    • 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
    • Federarm 5-polig NRH gerader Abgang
    • 0379528
    • FA AC3000
    • Stop 7-11KG
    • 0385719
    • FA AC 2000 NRH mobil 3p
    • 12-18kg NG
    • 1387323
    • Federarmsicherungssegment AC3000
    • 1387324
    • Federarmsicherungssegment AC2000
    • 1388338
    • Federarm 12-18 kg 3 polig
    • HEL2
    • 1388339
    • Federarm 12-18 kg 5 polig HEL2
    • 1388340
    • Federarm 12-18 kg 9 polig (HELION)
    • 1408906
    • FA AC2 Stop max 11kg
    • 1471010
    • FA AC2000 3p
    • 12-18kg
    • 1471011
    • FA AC2000 Stop 12-18kg
    • 1471012
    • FA AC2000 NRH 3p
    • 12-18kg
    • 1471013
    • FA AC2000
    • 7p
    • 12-18kg
    • 1471014
    • FA AC2000 NRH 7p
    • 12-18kg
    • 1471015
    • FA AC3000 3p
    • 23-30kg
    • 1471016
    • FA AC2000 Stop 6-11kg
  • Description
    • STATIV MOBIL TL1000
    • 3P + FA SWING
Amount recalled
9,287 units total

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 3, 2017 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.