FDA Devices recall · Reported October 31, 2018
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.
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 U…
Stryker Medical Division of Stryker Corporation recalled Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix sy… - a moderate-severity action.
Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix sy… was recalled by Stryker Medical Division of Stryker Corporation in October 31, 2018. Reason: Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond …. Check the official notice for the remedy. Verify recall #Z-0235-2019 with the FDA Devices before acting.
The recall
Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond ….
- Moderate
- severity level
- 389 units
- affected scope
- Class II
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0235-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0235-2019 |
| Date reported | October 31, 2018 |
| Date initiated | September 6, 2018 |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 389 units |
| Distribution | Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0235-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026