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Terminated

Arctic Sun Temperature Management System

FDA Recall Z-0436-05 · Posted 2005-01-26

Recalling FirmMEDIVANCE INC.
Recall StatusTerminated
Product CodeDWJ
Date Initiated2005-01-05
Date Terminated2005-03-25
Product Quantity67 units

Reason for Recall

Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

Firm Action

US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010338ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200Medivance, Inc. · 2001-03-07K002577ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADSMedivance, Inc. · 2000-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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