Stryker Altrix Temperature Management System Recalled for Alarm Faults
Stryker is recalling 389 Altrix Precision Temperature Management Systems due to frequent alarms and mechanical interference faults.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes functional faults (alarm fatigue, mechanical interference) but does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 389 units of the Altrix Precision Temperature Management System, Model 8001. The affected units were manufactured between October 4, 2016, and June 30, 2017, and were distributed nationwide in the United States as well as in Australia, Canada, the Netherlands, Switzerland, and the United Kingdom.
The recall is due to three specific issues: users may experience alarm fatigue from frequent alarms related to patient temperature deviations beyond 0.5°C in Automatic mode; users may encounter a Remove from Use code 9 (RFU 9) fault condition related to inadvertent flow alarms; and users may experience a code RFU 27 fault condition related to mechanical interference between the device fan and filter.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Stryker is the recalling firm responsible for the corrective action.
The recalled product
- 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
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 389
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model numbers/ UDI: 8001000001 07613327277555
- 8001000003 07613327277562
- 8001000008 07613327277630
- 8001000015 07613327277722
- 8001000016 07613327277586
- 8001000017 07613327277609
- 8001000018 07613327277678
- 8001000019 07613327277623
- 2016 and June 30
Distribution
Distributed nationwide across the United States.
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