Health product recall

Arctic Sun 5000 and Arctic Sun Stat

Brand(s)
Last updated

Summary

Product
Arctic Sun 5000 and Arctic Sun Stat
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Arctic Sun 5000

More than 10 numbers, contact manufacturer.

5000-00-00
5000-00-00L

Arctic Sun Stat

More than 10 numbers, contact manufacturer.

6000-00-00
6000-00-00L

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Medivance, Inc.
321 South Taylor Avenue, Louisville, Colorado, United States, 80027
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75812

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