Stryker Medical Division of Stryker product recalled over fire hazard

Recall date

September 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Medical Division of Stryker Corporation recalls Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating…

Recall number

Z-0235-2019

FDA classification

Class II

Brand / firm

Stryker Medical Division of Stryker Corporation

Sold / distributed

Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom

Why it was recalled

Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.