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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENDEX CORP GENDEX GX-770; EXTRAORAL SOURCE X-RAY SYSTEM
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GENDEX CORP GENDEX GX-770; EXTRAORAL SOURCE X-RAY SYSTEM Back to Search Results
Model Number GX-770
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2014
Event Type  malfunction  
Event Description
The tubehead of the device fell off the arm and hung by the wires.The device was not being used on patients at time of incident, there were no injury to patient nor office staff.
 
Manufacturer Narrative
The device was in the field for more than 15 years.The device was not made available to the manufacturer for further diagnosis.The device was evaluated and repaired by the distributor at the customer's site using customer-provisioned replacement parts.This model was discontinued in 2010 and no longer manufactured or distributed.This concludes our investigation.
 
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Brand Name
GENDEX GX-770
Type of Device
EXTRAORAL SOURCE X-RAY SYSTEM
Manufacturer (Section D)
GENDEX CORP
901 west oakton st.
des plaines IL 60018 188
Manufacturer Contact
ruth pui
1910 north penn rd.
hatfield, PA 19440
2679541479
MDR Report Key3745445
MDR Text Key4226669
Report Number2530069-2014-00001
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 Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGX-770
Device Catalogue Number0.820.0146
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/02/2014
Initial Date FDA Received01/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/1988
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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