TempSure Vitalia (2018-08-13)
- Starting date:
- August 13, 2018
- Posting date:
- August 31, 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-67630
Affected products
TempSure Vitalia
Reason
There is no known defectiveness or possible defectiveness for this device. This recall is being initiated to address concerns with the specific claims being made with the Vitalia product, and the actual indications that were cleared in the license.
Affected products
TempSure Vitalia
Lot or serial number
All lots.
Model or catalog number
100-7037-200
100-7037-300
Companies
- Manufacturer
-
Cynosure, Inc. DBA Ellman,
400 Karin Lane,
Hicksville
11801
New York
UNITED STATES