Signa HDe 1.5T MRI System and Signa Explorer (2018-11-19)
- Starting date:
- November 19, 2018
- Posting date:
- November 30, 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-68504
Affected products
A. Signa HDe 1.5T MRI System
B. Signa Explorer
Reason
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 software version is loaded on the Brivo MR355, Optima 360, Signa Profile, Signa Ovation HD, Signa Ovation .35T, Signa HFO, Signa HDE, Signa Ovation with Excite, 0.7T Signa Openspeed, Signa Infinity with Excite Technology, Signa Excite 3T and 1.5T Signa HDXT Systems the images can be flipped left/right and/or there can be patient data mismatch.
If the incorrect version is loaded on the Signa Infinity or the Signa Infinity Twinspeed System this could result in slice mis-registration.
If the incorrect software version is loaded on the Signa Creator or the Signa Explorer, and the user initiates a TPS (transceiver processing and storage) reset during a patient scan, the RF power monitor will be disabled for the remainder of the scan and unable to detect a subsequent failure of the RF transmit function. This could result in the in higher than expected thermal dose and localized heating to the patient.
If the incorrect software version is loaded on the GE Signa OpenSpeed System a patient's hand may be pinched if the patients puts his/her hand between the on top of the coil (CTL array and body flex) and ceiling of the magnet bore while the patient table is moving into the bore.
Affected products
A. Signa HDe 1.5T MRI System
Lot or serial number
00000008704YR9
00000009948YR1
00000010023YR0
00000010685YR6
00000010833YR2
00000011827YR3
Model or catalog number
S7505KY
Companies
- Manufacturer
-
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
NO. 266 JINGSAN ROAD
TIANJIN
300308
CHINA
B. Signa Explorer
Lot or serial number
3793TA7
Model or catalog number
6433266-1
Companies
- Manufacturer
-
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
NO. 266 JINGSAN ROAD
TIANJIN
300308
CHINA