Health product recall

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