Brand Name | EASYDIAGNOST ELEVA DRF |
Type of Device | SYSTEM, X-RAY, STATIONARY |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS DMC GMBH |
roentgenstr. 24 |
hamburg 22335 |
GM 22335 |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
dusty
leppert
|
roentgenstr. 24 |
hamburg 22335
|
GM
22335
|
405078-229
|
|
MDR Report Key | 6120868 |
MDR Text Key | 60904523 |
Report Number | 3003768251-2016-00009 |
Device Sequence Number | 1 |
Product Code |
KPR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031535 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
10/28/2016 |
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 |
No Information
|
Device Model Number | 706050 |
Device Catalogue Number | 706050 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/15/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/28/2016 |
Initial Date FDA Received | 11/22/2016 |
Supplement Dates Manufacturer Received | 10/28/2016
|
Supplement Dates FDA Received | 09/27/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|