Arctic Sun 5000 and Arctic Sun Stat
Brand(s)
Last updated
Summary
Product
Arctic Sun 5000 and Arctic Sun Stat
Issue
Medical devices - Performance issue
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 |
Arctic Sun Stat |
More than 10 numbers, contact manufacturer. |
6000-00-00 |
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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