Reported Aug 7, 2024 · Ongoing
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner,…
Medivance Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medivance Inc. · 321 S Taylor Ave Unit 200 · Louisville, CO · 80027-3600
Is this the product you have?
16 of 16 products
| # | Product as published |
|---|---|
| 1 | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00 |
| 2 | Arctic Sun STAT Loaner, NA/6000-00-00L |
| 3 | Arctic Sun Stat EU UK/600001 |
| 4 | Arctic Sun Stat Taiwan/600006 |
| 5 | Arctic Sun Stat Japan/600020 |
| 6 | Arctic Sun 5000, NA/5000-00-00 |
| 7 | Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E |
| 8 | Loaner, Arctic Sun M5000, NA/5000-00-00L |
| 9 | Arctic Sun 5000, EU/5000-1-01 |
| 10 | Loaner, Arctic Sun M5000, EU/5000-01-01L |
| 11 | Arctic Sun 5000, UK/5000-01-02 |
| 12 | Arctic Sun 5000, Australia/5000-01-03 |
| 13 | Arctic Sun 5000, China/5000-01-04 |
| 14 | Arctic Sun 5000, Brazil/5000-01-05 |
| 15 | Arctic Sun 5000, Switzerland/5000-01-07 |
| 16 | Arctic Sun 5000, South Africa/5000-01-08 |
- Lot codes and dates
- REF/UDI-DI/Software6000-00-00/00801741161513/v1.0.5 and prior, 6000-00-00L/00801741161520/v1.0.5 and prior, 600001/00801741226380/v2.1.1.0 and prior, 600006/00801741226397/v2.1.1.0 and prior, 600020/00801741226403/v2.1.1.0 and prior, 5000-00-00/00801741080142/v3.0.2 and prior, 5000-00-00E/00801741127755/v3.0.2 and prior, 5000-00-00L/00801741080159/v3.0.2 and prior, 5000-1-01/00801741186134/v3.0.2 and prior, 5000-01-01L/00801741186141/v3.0.2 and prior, 5000-01-02/00801741170003/v3.0.2 and prior, 5000-01-03/00801741222818/v3.0.2 and prior, 5000-01-04/00801741144653/v4.0.0 and prior, 5000-01-05/00801741222825/v3.0.2 and prior, 5000-01-07/00801741222832/v3.0.2 and prior, 5000-01-08/00801741222849/v3.0.2 and prior All serial numbers
- Amount recalled
- 10507
Where it was sold
Why it was recalled
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
This product could cause temporary or reversible health problems — stop using it.
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