Signa Horizon LX Magnetic Resonance System, Signa Infinity 1.5T TwinSpeed Excite MR System, Signa HDxt 1.5T and 3.0T MR System (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-68502
Affected products
A. Signa Horizon LX Magnetic Resonance System
B. Signa Infinity 1.5T TwinSpeed Excite MR System
C. Signa HDxt 1.5T MR System
D. Signa HDxt 3.0T MR System
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 Horizon LX Magnetic Resonance System
Lot or serial number
0000098-1219-2
Model or catalog number
46-265300G1
Companies
- Manufacturer
-
GE Medical Systems LLC
3000 North Grandview Blvd
Waukesha
53188
Wisconsin
UNITED STATES
B. Signa Infinity 1.5T TwinSpeed Excite MR System
Lot or serial number
9520M28
Model or catalog number
M3000TD
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
C. Signa HDxt 1.5T MR System
Lot or serial number
00000283347MR3
Model or catalog number
1.5T SIGNA HDXT MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES
D. Signa HDxt 3.0T MR System
Lot or serial number
00000007532YR5
Model or catalog number
SIGNA HDXT 3.0T MR SYSTEM
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Wisconsin
UNITED STATES