Use cautionMedical device recall · FDA · Published September 6, 2018
Stryker Altrix Precision Temperature Management System Model 8001: Risk of alarm fatigue
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
Take action
Contact the company
📍Recalling firmStryker Medical Division of Stryker Corporation3800 E Centre Ave · Portage, MI 49002-5826
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/69906-stryker-altrix-precision-temperature-management-system-model-8001-risk-of.
“Stryker Altrix Precision Temperature Management System Model 8001: Risk of alarm fatigue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69906-stryker-altrix-precision-temperature-management-system-model-8001-risk-of. Based on FDA recall #Z-0235-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0235-2019%22&limit=1).
The FDA announced on 2018-09-06 that Stryker Medical Division of Stryker Corporation is recalling the Altrix Precision Temperature Management System Model 8001 due to potential alarm fatigue and fault conditions. The agency issued recall number Z-0235-2019 for the Class II device.
How to tell if you have it
Brand: Stryker
Product: Altrix Precision Temperature Management System
Manufacture dates: October 4, 2016 to June 30, 2017
Units affected: 389
The hazard
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C while in Automatic mode. Users may also experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms, or code RFU 27 fault condition relating to mechanical interference between the device fan and filter.
Context
GovInfoNow's records show Stryker Medical Division of Stryker Corporation has 17 other recalls on record since 2017-07-21. Other recent recalls include the Stryker Cub Pediatric Crib Model FL19H (2026-02-18), the Stryker Arise 1000EX Mattress (2025-10-31), and the Stryker ProCuity Bed Series 3009 (2023-08-30). Other recent recalls of similar products include the Gentherm Blanketrol III Model 233 Thermal Regulator (2026-07-13), the Gentherm Blanketrol II (2026-07-13), and the Covidien Mon-a-Therm Temperature Probe (2026-04-23).
How to tell if you have this one
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.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Review the device for error codes like RFU 9 or RFU 27 that indicate mechanical issues with the fan and filter.
Verify Model and Serial
Confirm the model number is 8001 and check the serial number against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
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.
Official source: FDA Recall #Z-0235-2019 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0235-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.