Signa Products
Last updated
Summary
Product
Signa Products
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Signa Hde 1.5t Mri System - Main Unit | 514747MRI, 604202MR, 514341MRI, 604520MR2 | S7505KY |
| Signa Artist | More than 10 numbers, contact manufacturer. | SIGNA ARTIST |
| Signa Explorer | 780964EXP, 604988MRI, 519824MR, 416431MR, 514765MRI, 604941MR1, 604822MRTS, 418691MR, 250782MR | 6433266-1 |
| Optima Mr360 - Main Unit | 403541MR, 604985MR1, 450670MR2 | 5433265-1, 5312366 (M50002BB) |
| Signa Voyager | 4964226MR81, 450688MR1, 780679MRV, 780699MRV, 780679AMSTMOBL, 306664MR1 | SIGNA VOYAGER |
Issue
GE healthcare (GEHC) MR systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet quench, potentially depriving the room of oxygen.
Recall start date: Jan 4, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
| Ge Healthcare (Tianjin) Company Limited |
|
No. 266 Jingsan Road, Tianjin China, 300308 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63831
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