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