|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Z-3021-2017 - Brivo MR355, Optima MR360
Product Usage:
The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan tim...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3022-2017 - Optima MR450 1.5T
Product Usage:
1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan ...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3023-2017 - Optima MR750 3.0T
Product Usage:
The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It ...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3024-2017 - Optima MR450w 1.5T
Product Usage:
The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3029-2017 - Signa PET/MR (K163619, K142098)
Product Usage:
The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registrati...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3026-2017 - SIGNA Creator, SIGNA ExplorerProduct Usage:
1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and ...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3027-2017 - 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant
Product Usage:
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3028-2017 - 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant
Product Usage:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high ...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|
Z-3025-2017 - Discovery MR750 3.0T
Product Usage:
Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and sho...
|
2
|
08/02/2017
|
GE Medical Systems, LLC
|