Public recall detail

CARESCAPE Monitoring System

2024-05-06

medium
Recall Safety notice
Quick summary

Quick summary: CARESCAPE Monitoring System. Date: 2024-05-06.

Recommended action

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

Recall details

Quick summary: CARESCAPE Monitoring System. Date: 2024-05-06.

Official details

Affected product details

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

BrandGE Healthcare Finland Oy
ProductCARESCAPE Monitoring System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75486

Affected products

ProductCARESCAPE B650
LotMore than 10 numbers, contact manufacturer.
ModelMBB323 MBB313
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCARESCAPE B650
ProductCARESCAPE Canvas™ Smart Display
LotMore than 10 numbers, contact manufacturer.
Model5897060
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCARESCAPE Canvas™ Smart Display
ProductCARESCAPE Monitor B850
LotMore than 10 numbers, contact manufacturer.
Model2095802-001 MBC313 MBC323
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCARESCAPE Monitor B850
ProductCARESCAPE Canvas™
LotMore than 10 numbers, contact manufacturer.
Model5876727
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCARESCAPE Canvas™

Issue

Potential for loss of monitoring if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. Recall start date: April 22, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesGE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, Finland, 00510
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75486
Background{}
CompaniesGE Healthcare Finland Oy Kuortaneenkatu 2, Helsinki, Finland, 00510
AudiencesHealthcare
Source updated2024-05-06

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

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