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No image published for this recall

Signa products

Official notice

18 Jan 2022

Last checked

18 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Signa products. 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 Published 2022-01-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63831

Official notice

2022-01-18

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63831

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Affected products

Product 1

Affected Products - Signa Hde 1.5t Mri System - Main Unit, Lot or serial number - 514747MRI, 604202MR, 514341MRI, 604520MR2, Model or catalog number - S7505KY

Product 2

Affected Products - Signa Artist, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - SIGNA ARTIST

Product 3

Affected Products - Optima Mr360 - Main Unit, Lot or serial number - 403541MR, 604985MR1, 450670MR2, Model or catalog number - 5433265-1, 5312366 (M50002BB)

Product 4

Affected Products - Signa Voyager, Lot or serial number - 4964226MR81, 450688MR1, 780679MRV, 780699MRV, 780679AMSTMOBL, 306664MR1, Model or catalog number - SIGNA VOYAGER

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: GE Healthcare [tianjin], Signa.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63831

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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