GENDEX GX-770
Received Feb 26, 2019 · Event occurred Feb 4, 2019
Report 2530069-2019-00001 · MDR key 8369709
Device
Generic name
Unit, X-ray, Extraoral With Timer
Manufacturer
Dental Imaging Technologies CorporationModel number
GX-770Catalog number
0.820.0146
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
PATIENT INDENTIFIER HAS BEEN CORRECTED TO INCLUDE THE CORRECT PATIENT IDENTIFIER.
Additional Manufacturer Narrative
THE UNIT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CAUSE AS TO THE MALFUNCTION OF THE UNIT COMPONENT CANNOT BE DETERMINED. THE ACTUAL DATE OF MANUFACTURE CANNOT BE DETERMINED; HOWEVER, THE GX-770 WAS DISCONTINUED FROM SALE ON 03/31/2010 AND MANUFACTURER SUPPORT OF THE DEVICE ENDED ON 03/31/2017. THIS CONCLUDES THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THE HORIZONTAL ARM BROKE LOOSE WHERE IT MEETS THE CONTROL PANEL. THERE WAS NO REPORT OF PATIENT OR USER INVOLVEMENT. NO INJURIES WERE REPORTED.