Health product recall

Signa Explorer/Voyager/Artist (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-75933

Last updated:
2021-06-30

Affected Products

A. SIGNA EXPLORER
B. SIGNA VOYAGER
C. SIGNA ARTIST

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. SIGNA EXPLORER

Lot or serial number

416431MR
418691MR
519824MR
604988MRI
780964EXP

Model or catalog number

6433266-1

Companies
Manufacturer

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

NO. 266 JINGSAN ROAD

TIANJIN

300308

CHINA

B. SIGNA VOYAGER

Lot or serial number

306664MR1
450688MR1
780679MRV
780699MRV

Model or catalog number

SIGNA VOYAGER

Companies
Manufacturer

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

NO. 266 JINGSAN ROAD

TIANJIN

300308

CHINA

C. SIGNA ARTIST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SIGNA ARTIST

Companies
Manufacturer

GE HEALTHCARE (TIANJIN) COMPANY LIMITED

NO. 266 JINGSAN ROAD

TIANJIN

300308

CHINA