• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDEX DENTAL SYSTEMS GX-770 EXTRAORAL SOURCE X-RAY SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENDEX DENTAL SYSTEMS GX-770 EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number GX-770
Device Problems Device Maintenance Issue (1379); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problems Abrasion (1689); Erythema (1840)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
The device was manufactured in march of 1991 and has been in the field for over 25 years. The model was discontinued in march of 2010. The device will not be returned to the manufacturer for further evaluation because the customer re-attached the tube head and elected to keep the device. The customer indicated that the device had not been maintained in accordance with the device labeling. The gx-770 user manual (415-0169) states that in the interest of equipment safety, a maintenance program must be established by the device owner and periodic maintenance performed by fully qualified personnel on an annual basis. This concludes our investigation.
 
Event Description
The operator was positioning the device for a scan when the tube head became dislodged and fell on the patient. The patient sustained a cut to the upper lip and redness of the skin (erythema) where the tube head made contact. The patient did not seek medical attention and no serious injury has been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGX-770
Type of DeviceEXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDEX DENTAL SYSTEMS
901 west oakton street
des plaines IL 60018 1884
Manufacturer (Section G)
GENDEX DENTAL SYSTEMS
1910 north penn road
hatfield PA 19440
Manufacturer Contact
martin rajchel
2800 crystal drive
hatfield, PA 19440
2159540338
MDR Report Key6388452
MDR Text Key69399864
Report Number2530069-2017-00007
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Dental Assistant
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dental Assistant
Device Model NumberGX-770
Device Catalogue Number0.820.0146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/1991
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-