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Arctic Sun Temperature Management Systems, Name/REF recallZ-2457-2024 · Medivance Inc. · initiated Jun 27, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medivance Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

On 6/27/24, correction notices were sent to customers and distributors informing them of the following: Advice for Clinical Users: 1) Systems contains the following two fixed alarms when the device is operating in patient control mode: - Alarm 10 will alert if the patient s temperature and/or water temperature is below 31 degrees Celsius and the water temperature is below 31 degrees Celsius. - Alarm 08 will alert if the patient s temperature and/or water temperature is above 39.5 degrees Celsius. 2) Customers should continue to use the customizable Patient Temperature Low (Alarm 11) and Patient Temperature High (Alarm 09) alarms on their devices. Both alarms are available when the device is operating in patient control mode. Customers should set these alarms to the lowest and highest temperatures they feel are acceptable for the specific patient being treated. Default settings are 30 degrees Celsius and 44 degrees Celsius and alert independent of water temperature. For Arctic Sun STAT, refer to the Operator Manual for Alarm 9 on page 39 and Alarm 11 on page 40. For Arctic Sun 5000, refer to the Service Manual for Alarms 9 and 11 on page 9. 3) As instructed in the Operating Manual, always empty Arctic Gel Pads when therapy is ended, even if the stop in therapy is only temporary. Failure to do so may result in overfill of the water reservoir and this can affect temperature management. -Complete and return the response form via email to [email protected] -Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred, to ensure they are also aware of this Medical Device Recall. -Firm is developing a software update and will provide an additional communication with the status of the software update release by February 28, 2025. If you have any questions, contact the firm's Medical Information Services that are available 24/7 at 1-866-840-9776.

Recall details

Recall number
Z-2457-2024
Status
Open, Classified
Initiated by the company
Jun 27, 2024
Posted by the FDA
Jul 31, 2024
Recalling firm
Medivance Inc.
Quantity
10507
Product code
DWJ
FDA submissions
K161602, K200225
Distribution
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

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

REF/UDI-DI/Software: 6000-00-00/00801741161513/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.

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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