# FDA recall Z-0235-2019

> **Stryker Medical Division of Stryker Corporation** · Class II · device recall initiated 2018-09-06.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0235-2019
- **Recalling firm:** Stryker Medical Division of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-06
- **Report date:** 2018-10-31
- **Termination date:** 2020-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2019

## Citation

> AI Analytics. FDA recall Z-0235-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0235-2019. Source: US FDA. Licensed CC0.

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