Recall Z-0436-05 ยท DWJ System, Thermal Regulating
MEDIVANCE INC.
Arctic Sun Temperature Management System
| Date | Jan 26, 2005 (initiated Jan 5, 2005) |
| Status | Terminated |
| Reason | Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature. |
| Root cause | Other |
| Action | US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation. |
| Quantity | 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. |
| FDA record | Open on fda.gov |