Brand Name | GENDEX |
Type of Device | EXTRAORAL SOURCE X-RAY SYSTEM |
Manufacturer (Section D) |
PALODEX GROUP OY |
160 nahkelantie |
tuusula, uusimaa 04300 ,FIN |
FI 04300,FIN |
|
Manufacturer (Section G) |
PALODEX GROUP OY |
160 nahkelantie |
|
tuusula, uusimaa 04300 , FI |
FI
04300, FIN
|
|
Manufacturer Contact |
rainer
harjunpää
|
160 nahkelantie |
tuusula, uusimaa 04300-, FI
|
FI
04300, FIN
|
|
MDR Report Key | 15006088 |
MDR Text Key | 303919501 |
Report Number | 3005383085-2022-00002 |
Device Sequence Number | 1 |
Product Code |
EHD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K041050 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Dentist
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
07/11/2022 |
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 Number | GXPS 500 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/20/2022
|
Initial Date FDA Received | 07/13/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/02/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-0839-2020-Z-0842-2020 |
Patient Sequence Number | 1 |
|
|