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Health product recall

HELIOS 3000 TRACK MOUNT DENTAL LIGHT (2016-02-26)

Starting date:
February 26, 2016
Posting date:
March 10, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-57472

Affected Products

  1. HELIOS 3000 TRACK MOUNT DENTAL LIGHT

Reason

The Pelton & Crane dental lights were erroneously distributed missing two (2) 8/32x3/16 set screws. The two missing set screws help secure the light from unscrewing and falling off the column during the life of the device. This failure could result in potential injury to either the patient or the end user.

Affected products

  1. HELIOS 3000 TRACK MOUNT DENTAL LIGHT

Lot or serial number

Not applicable

Model or catalog number

HL3T

Companies
Manufacturer

KAVO DENTAL TECHNOLOGIES, LLC

DBA PELTON AND CRANE

11727 FRUEHAUF DRIVE

CHARLOTTE

28273

North Carolina

UNITED STATES