Public recall detail

Optima Mr430s 1.5t - Main Unit

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Recall Safety notice
Quick summary

Quick summary: Optima Mr430s 1.5t - Main Unit.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Optima Mr430s 1.5t - Main Unit.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandGe Medical Systems, LLC
ProductOptima Mr430s 1.5t - Main Unit
IssueMedical devices - Quality
Recall classType II
IdentificationRA-63826

Affected products

ProductOptima Mr430s 1.5t - Main Unit
Lot403220MR1, 514697ONI, 905521ONI
ModelOPTIMA MR430S 1.5T (5000-0002)
Serial number403220MR1, 514697ONI, 905521ONI
DescriptionOptima Mr430s 1.5t - Main Unit

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Radiology
CompaniesGe Medical Systems, LLC 301 Ballardvale St., Wilmington, Massachusetts United States, 01887
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63826
Background{}
CompaniesGe Medical Systems, LLC 301 Ballardvale St., Wilmington, Massachusetts United States, 01887
AudiencesGeneral public Health professionals Hospitals
Source updated2022-01-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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