Z-0436-05

Arctic Sun Temperature Management System

Name: Z-0436-05 Arctic Sun Temperature Management System
Creator: Medivance Inc.
Published: 2005-01-05
License: https://open.fda.gov/license/

Medivance Inc. / initiated 2005-01-05 / Terminated

FDA source

MEDIVANCE INC. began a recall of Arctic Sun Temperature Management System on 2005-01-05. The reason FDA records is "Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0436-05
Status: Terminated
Initiated: 2005-01-05
Posted: 2005-01-26
Terminated: 2005-03-25
Recalling firm: Medivance Inc.
Product: Arctic Sun Temperature Management System
Product code: DWJ System, Thermal Regulating
Reason for recall: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
FDA root cause: Other
Action: US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.
Quantity in commerce: 67 units
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 codes and lots: Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080

Product code DWJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)