Kavo Dental Technologies, DBA Pelton and Crane Recalls Dexis Titanium Digital X-Ray Sensor

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

• Reason
• Affected products

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