Devices

Device Recall hypo/hyperthermia system

Model / Serial
Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
AL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.
Product Description
Arctic Sun Temperature Management System
Manufacturer
MEDIVANCE INC.
1 Event
- Recall of Device Recall hypo/hyperthermia system

Manufacturer

MEDIVANCE INC.

Manufacturer Address
MEDIVANCE INC., 1172 W Century Dr Ste 240, Louisville CO 80027-1681
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)