CU-1000 Halogen Curing Light (2018-04-06)
- Starting date:
- April 6, 2018
- Posting date:
- June 6, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66976
Affected products
CU-1000 Halogen Curing Light
Reason
Henry Schein Inc. is initiating a voluntary product recall for the Henry Schein CU-1000 Halogen Light for Serial Number 17c0001 to 17c0252. The manufacturer has stated that the heat shield/filter is missing inside nose cone. This will result in excessive heat transferred to patient, causing discomfort and burning sensation.
Affected products
CU-1000 Halogen Curing Light
Lot or serial number
17C0001 to 17C0252
Model or catalog number
9004542
Companies
- Manufacturer
-
HENRY SCHEIN Inc.
135 Duryea Road
Melville
11747
New York
UNITED STATES