Altrix¿ Precision Temperature Management System Model: 8001Product… — Class II medical device recall Z-0235-2019
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-10-31, distributed nationwide. Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0
| Recall number | Z-0235-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-09-06 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, GB, NL |
| Quantity | 389 units |
| UPC / GTIN / UDI-DI | 07613327277555, 07613327277562, 07613327277586, 07613327277609, 07613327277623, 07613327277630, 07613327277678, 07613327277722, 07613327277777 |
| Serial numbers | 201609000500001, 201609000500002, 201609000500003, 201609000500004, 201609000500005, 201609000500006, 201609000500007, 201609000500008, 201609000500009, 201609000500010, 201609000500011, 201609000500012, 201609000500013, 201609000500014, 201609000500039, 201609000500040, 201609000500041, 201609000500042, 201609000500043, 201609000500050, 201610000500062, 201610000500063, 201610000500066, 201610000500067, 201610000500069 and 76 more |
| Model numbers | 8001, 8001PRODUCT |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0235-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.