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

• Reason
• Affected products

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