Health product recall

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