Health product recall

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