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:
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
