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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