Brand Name | SOMATOM.GO TOP |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS HEALTHCARE GMBH |
siemenstrasse 1 |
forchheim, 91301 |
GM 91301 |
|
MDR Report Key | 8758139 |
MDR Text Key | 190827559 |
Report Number | 3004977335-2019-85319 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
PMA/PMN Number | K173632 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
06/10/2019 |
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 | 11061640 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
06/10/2019 |
Initial Date FDA Received | 07/03/2019 |
Supplement Dates Manufacturer Received | 07/19/2019
|
Supplement Dates FDA Received | 07/23/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|