Expert DC Dental X-ray (2014-08-22)

Starting date:
August 22, 2014
Posting date:
September 3, 2014
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-41265

Recalled Products   

Expert DC Dental X-ray 

Reason

Two failures of the spring link components within the articulated arm assembly were observed on expert DC production line AR manufacturer's Hatfield facility in July 2014. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.

Affected products

Expert DC Dental X-ray 

Lot or serial number

Serial #1016430
Serial # 2015566, #2015561, #2015562
Serial #2014383, #2015522

Model or catalog number

110-0207G1
110-0207G2

Companies
Manufacturer
Imaging Sciences Int'l LLC
DBA Gendex Dental Systems
1910 Penn Road
Hatfield
19440
Pennsylvania
UNITED STATES