FDA Medical Device Recalls (openFDA)
MEDIVANCE INC.: Arctic Sun Temperature Management System
- Recall number
- Z-0436-05
- Recalling firm
- MEDIVANCE INC.
- Product
- Arctic Sun Temperature Management System
- Status
- Terminated
- Initiated
- 2005-01-05
- Posted
- 2005-01-26
- Terminated
- 2005-03-25
- 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.
- Lot, serial or model codes
- Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
- 510(k) numbers
- ["K010338","K002577"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 3003329224
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28