Known Identifiers & Locations
FEI Numbers
1720753, 3004526608
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (4)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0004-2010 |
GE OEC 9900 Elite ESP
To produce mobile fluoroscopic images of human anatomy.
Reason: A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
|
2009-08-12 |
Terminated
|
View Details
|
| Z-0005-2010 |
GE OEC 9900 Elite GSP Fluoroscopes
To produce mobile fluoroscopic images of human anatomy.
Reason: A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
|
2009-08-12 |
Terminated
|
View Details
|
| Z-0023-2016 |
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Reason: Images may be missing when a system parameter MapRoute is set to a value greater than 1.
|
2015-09-16 |
Terminated
|
View Details
|
| Z-0039-2025 |
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers:
a) 2089507-120;
b) 2089507-129;
c) 2089507-131;
d) 2089507-135;
e) 2089507-136;
f) 2089507-140;
g) 2089507-144;
h) 2089507-145;
i) 2089507-149;
j) 2089507-153;
k) 2089507-154;
l) 2089507-155;
m) 2089507-156;
n) 2089507-157;
o) K2037DAED;
p) K2037DBED;
q) K2037DED;
r) K2037DJED;
s) K2037DNED;
t) K2042TTED;
u) K2049DC;
v) K2049DD;
w) K2049DF;
x) P2037DAED;
y) P2037DBED;
z) P2037DED;
aa) To be provided
Reason: GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
|
2024-08-29 |
Open, Classified
|
View Details
|
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