Recall record at a glance
| Official record | Z-2457-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Medivance Inc. |
| Report date | Aug 7, 2024 |
| Recall initiation date | Jun 27, 2024 |
| Quantity | 10507 |
| Location | Louisville, CO, United States |
Official product description
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08
Why the product 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.
Distribution information
Worldwide - US Nationwide distribution including in the states of IN, OK, MO, FL, CT, KS, TX, NJ, CA, OR, HI, IL, WI, VA, KY, NH, CO, NV, LA, NC, ID, UT, GA, SC, TN, MD, PA, IA, MA, OH, NY, DE, MI, NM, WV, AZ, DC, VT, MN, SD, AL, AR, WA, NE, ND, MT, AK, MS, ME, WY, RI, PR, OK, OR and the countries of CA, DE, AT, BE, FI, TR, NO, DK, JP, ES, AU, FR, GB, IT, SE, PT, AE, SA, ZA, RU, KR, CY, TH, GR, TW, MY, OM, CN, SG, GI, NL, IL, CZ, RO, CH, RE, PL, PE, SK, AR, IN, CL, MX, QA, BR, SI, HU, JO, LU, KW, PH, NZ, HK, VN, IR, BN, UA, ID, CO, KZ, HR, IS, GU, GE, BH, EE, AM, PA, KR, CL, TH, MY, JP, AU, BD, BE, TW
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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