Signa 1.5T EXCITE HD - Magnet, Signa EXCOTE 3.0T G3 Magnet, Signa HDxt 1.5T MR System - Main Unit, Signa Infinity 1.5T TwinSpeed with Excite, 1.5T Signa HDx MR System - Main Unit (2018-06-07)
- Starting date:
- June 7, 2018
- Posting date:
- June 22, 2018
- 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-67090
Affected products
A. Signa 1.5T EXCITE HD - Magnet
B. 1.5T Signa HDx MR System - Main Unit
C. Signa Infinity 1.5T TwinSpeed with Excite
D. Signa EXCOTE 3.0T G3 Magnet
E. Signa HDxt 1.5T MR System - Main Unit
Reason
The following issue is being addressed by GE Healthcare File No. FMI 60936: GE Healthcare has recently become aware that 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. If the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Affected products
A. Signa 1.5T EXCITE HD - Magnet
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SIGNA 1.5T EXCITE HD MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
UNITED STATES
B. 1.5T Signa HDx MR System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1.5T SIGNA HDX MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
UNITED STATES
C. Signa Infinity 1.5T TwinSpeed with Excite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M3000TD
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
UNITED STATES
D. Signa EXCOTE 3.0T G3 Magnet
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M3333TD
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
UNITED STATES
E. Signa HDxt 1.5T MR System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1.5T SIGNA HDXT MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
UNITED STATES