DISCOVERY MR750 MR SYSTEM, DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM, SIGNA HDXT 1.5T MR SYSTEM, DISCOVERY MR450 1.5T MR SYSTEM (2021-06-16)
- Starting date:
- June 16, 2021
- Posting date:
- June 30, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75937
Last updated: 2021-06-30
Affected Products
A. DISCOVERY MR750 MR SYSTEM - MAIN UNIT
B. SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT
C. DISCOVERY MR450 1.5T MR SYSTEM - MAIN UNIT
D. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 16CH
E. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 32CH
F. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM
G. DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
H. SIGNA PET/MR
I. SIGNA PIONEER
J. SIGNA ARCHITECT
K. SIGNA PREMIER
Reason
The "Patient Orientation" button can inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan. This can result in incorrectly annotated and/or flipped images and potentially result in improper medical treatment.
Affected products
A. DISCOVERY MR750 MR SYSTEM - MAIN UNIT
Lot or serial number
416595MR1
514848MR1
519685MR3T
604875MR750
902473MR2
905522MR3T
Model or catalog number
DISCOVERY MR750 3.0T
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
B. SIGNA HDXT 1.5T MR SYSTEM - MAIN UNIT
Lot or serial number
514473MR1
KWMRIHDXT
Model or catalog number
1.5T SIGNA HDXT MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
C. DISCOVERY MR450 1.5T MR SYSTEM - MAIN UNIT
Lot or serial number
250727MR2
403541MR1
Model or catalog number
DISCOVERY MR450 1.5T MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
D. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 16CH
Lot or serial number
416212MR450
450466MR1
514697MR450
902893MR1
Model or catalog number
OPTIMA MR450W 1.5T
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
E. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - 32CH
Lot or serial number
403670MR1
613938MR1
780532MR1
Model or catalog number
M7004ZJ
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
F. OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M7000YN
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
G. DISCOVERY MR750W 3.0T MAGNETIC RESONANCE IMAGING SYSTEM - MAIN UNIT
Lot or serial number
506648MR4
613737MR1
Model or catalog number
DISCOVERY MR750W 3.0T
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
H. SIGNA PET/MR
Lot or serial number
604822MRP1
Model or catalog number
SIGNA PET/MR
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
I. SIGNA PIONEER
Lot or serial number
250598MR1
403253MR1
Model or catalog number
SIGNA PIONEER
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
J. SIGNA ARCHITECT
Lot or serial number
403777SIGNA3T
604582MR750
780699MR3T
905527MR1
E416249MR2
Model or catalog number
SIGNA ARCHITECT
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES
K. SIGNA PREMIER
Lot or serial number
514934MR4
Model or catalog number
SIGNA PREMIER
Companies
- Manufacturer
-
GE Medical Systems LLC
3200 North Grandview Blvd
Waukesha
53188
UNITED STATES