Stryker recalls Altrix Model 8001 units made between Oct 2016 and June 2017 due to potential alarm fatigue and device faults that could affect patient temperature monitoring.
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
Stryker is recalling Altrix Precision Temperature Management System Model 8001 units produced between October 2016 and June 2017. These devices may cause frequent alarms about patient temperature deviations or mechanical issues with the fan and filter, which could lead to improper temperature regulation during medical treatments.
The device may generate frequent alarms about patient temperature deviations beyond 0.5°C or trigger error codes related to mechanical interference between the fan and filter. This could cause the system to malfunction during temperature therapy, potentially leading to improper temperature regulation for patients.
Healthcare providers using the Altrix system for temperature regulation in medical treatments are most at risk. Patients receiving temperature therapy through this device could be affected if the system malfunctions.
Check for the Altrix Model 8001 with serial numbers listed in the recall notice. Units manufactured between October 4, 2016 and June 30, 2017 are affected.
Review the device for error codes like RFU 9 or RFU 27 that indicate mechanical issues with the fan and filter.
Confirm the model number is 8001 and check the serial number against the list provided in the recall notice.
The Altrix system is intended for circulating temperature-controlled warm or cold water via patient contact thermal transfer devices to regulate human body temperature in medical treatments.
Altrix Model 8001 units manufactured between October 4, 2016 and June 30, 2017 with specific serial numbers listed in the recall notice.
The device may cause frequent alarms about patient temperature deviations beyond 0.5°C or trigger error codes related to mechanical interference between the fan and filter.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0235-2019 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0235-2019 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
