Arctic Sun Temperature Management System
FDA device recall Z-0436-05 · posted 2005-01-26 · Terminated
Recall details
- Recalling firm
- MEDIVANCE INC.
- Reason for recall
- Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
- Action taken
- US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 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, N
- Date initiated
- 2005-01-05
- Date posted
- 2005-01-26
- Date terminated
- 2005-03-25
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (K010338) | Medivance, Inc. | 2001-03-07 |
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS (K002577) | Medivance, Inc. | 2000-10-26 |