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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
- 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
-
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