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Signa, Discovery, Optima Magnetic Resonance Systems and Components (various models) (2015-03-02)
- Starting date:
- March 2, 2015
- Posting date:
- April 27, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-52621
Recalled Products
A. 1.5T Signa Horizon Magnetic Resonance System
B. Signa 1.5T Excite HD - Magnet
C. 3.0T Signa HDX MR System Main Unit
D. 1.5t Signa HDX MR System - Main Unit
E. Discovery MR750 MR System - Main Unit
F. 1.5T Signa Infinity Twinspeed - Excite
G. Signa 1.5T Infinity Excite MR System
H. Signa HDXT 1.5T MR System - Main Unit
I. Discovery MR450 1.5T MR System - Magnet
J. Signa HDI 1.5T MRI System - 16 Channel Mobile
K. Optima MR450W MRI System - Main Unit - 16CH
L. Optima MR450W MRI System - Main Unit - 32CH
M. Optima MR450W MRI System - Main Unit GEM
Reason
The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates.
Affected products
A. 1.5T Signa Horizon Magnetic Resonance System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
B. Signa 1.5T Excite HD - Magnet
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
C. 3.0T Signa HDX MR System Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
D. 1.5t Signa HDX MR System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
E. Discovery MR750 MR System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
F. 1.5T Signa Infinity Twinspeed - Excite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
G. Signa 1.5T Infinity Excite MR System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicabl
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
H. Signa HDXT 1.5T MR System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
I. Discovery MR450 1.5T MR System - Magnet
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
J. Signa HDI 1.5T MRI System - 16 Channel Mobile
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
K. Optima MR450W MRI System - Main Unit - 16CH
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
L. Optima MR450W MRI System - Main Unit - 32CH
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES
M. Optima MR450W MRI System - Main Unit GEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable
Companies
- Manufacturer
-
Ge Medical Systems Llc
3200 North Grandview Blvd
Waukesha
Wisconsin
UNITED STATES