Reported Apr 6, 2016 · Terminated

Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals…

Pelton & Crane / Marus / DCI Equipment / KaVo

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: Pelton & Crane / Marus / DCI Equipment / KaVo · 11727 Fruehauf Dr · Charlotte, NC · 28273-6507

Is this the product you have?

  • Helios HL3T and HLT Track
  • Mounted Dental Lights Product UsageThe product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures
Lot codes and dates
  • 154 of 154 codes

    • Model/Serial No. - HLT-5535
    • 5543
    • 5536
    • 5537
    • 5538
    • 5556
    • 5540
    • 5541
    • 5545
    • 5546
    • 5515
    • 5500
    • 5503
    • 5520
    • 5521
    • 5547
    • 5548
    • 5549
    • 5550
    • 5551
    • 5552
    • 5510
    • 5558
    • 5522
    • 5523
    • 5524
    • 5525
    • 5526
    • 5527
    • 5528
    • 5529
    • 5530
    • 5531
    • 5532
    • 5501
    • 5502
    • 5504
    • 5505
    • 5534
    • 5508
    • 5509
    • 5533
    • 5516
    • 5517
    • 5518
    • 5519
    • 5544
    • 5553
    • 5554
    • 5555
    • 5542
    • 5557
    • 5506
    • 5507
    • 5511
    • 5498
    • 5539
    • 5499
    • 5512
    • 5513
Amount recalled
156 units

Where it was sold

Why it was recalled

The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 6, 2016 · Data as of Sep 19, 6:46 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.