Health product recall

Dexis Titanium (2019-04-28)

Starting date:
April 28, 2019
Posting date:
May 3, 2019
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-69836

Last updated: 2019-05-03

Affected Products

Dexis Titanium

Reason

The manufacturer was informed by the supplier on 12-Mar-2019 that these sensors' look up calibration files were incorrectly programmed during manufacture. This may result in a reduction of image quality, such as loss of imaging contrast or an increase in image 'noise'. The reduction of image quality may create a possibility for an undiagnosed condition or a mis-diagnosis.

Affected products

Dexis Titanium

Lot or serial number

S/N: 13097230

Model or catalog number

1.012.6180

Companies
Manufacturer
Kavo Dental Technologies, LLC
DBA Pelton and Crane
11727 Fruehauf Dr
Charlotte
28273
North Carolina
UNITED STATES