Public recall detail

Arctic Sun 5000 and Arctic Sun Stat

2024-07-12

medium
Recall Safety notice
Quick summary

Quick summary: Arctic Sun 5000 and Arctic Sun Stat. Date: 2024-07-12.

Recommended action

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

Recall details

Quick summary: Arctic Sun 5000 and Arctic Sun Stat. Date: 2024-07-12.

Official details

Affected product details

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

BrandMedivance, Inc.
ProductArctic Sun 5000 and Arctic Sun Stat
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75812

Affected products

ProductArctic Sun 5000
LotMore than 10 numbers, contact manufacturer.
Model5000-00-00 5000-00-00L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionArctic Sun 5000
ProductArctic Sun Stat
LotMore than 10 numbers, contact manufacturer.
Model6000-00-00 6000-00-00L
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionArctic Sun Stat

Issue

An internal investigation has determined that alarm 113 may not alert as expected when the device fails to reach the correct target water temperature while the device is operating in patient control mode. Recall start date: June 27, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesMedivance, Inc. 321 South Taylor Avenue, Louisville, Colorado, United States, 80027
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75812
Background{}
CompaniesMedivance, Inc. 321 South Taylor Avenue, Louisville, Colorado, United States, 80027
AudiencesHealthcare
Source updated2024-07-12

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

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