Brand Name | REVOLUTION CT |
Type of Device | COMPUTED TOMOGRAPHY X-RAY SYSTEM |
Manufacturer (Section D) |
GE MEDICAL SYSTEMS, LLC |
3000 n grandview blvd. |
waukesha, WI 53188 |
|
Manufacturer Contact |
susan
strasser
|
3000 n grandview blvd |
waukesha, WI
|
|
MDR Report Key | 11144306 |
MDR Text Key | 228022633 |
Report Number | 2126677-2021-00006 |
Device Sequence Number | 1 |
Product Code |
JAK
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K163213 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
01/10/2021 |
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 | CSRV12 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/12/2020
|
Initial Date FDA Received | 01/10/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/12/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | GEHC REF# 25496 |
Patient Sequence Number | 1 |
|
|