# Altrix Precision Temperature Management System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/altrix-precision-temperature-management-system-dwj>
- Manufacturer: [Stryker Medical](https://devicerts.com/manufacturers/stryker-medical) (United States)
- Device class: Class II (US FDA)
- FDA product code: DWJ

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K152266 · decision 2016-12-02 · decision SESE · status: Active

## Recalls

- Z-0235-2019 · Class II · terminated · initiated 2018-09-06: Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5C 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

## Identifiers

- 510(k) Number: K152266 [FDA 510(k)]
- FDA product code: DWJ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.5900 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Altrix Precision Temperature Management System, Stryker Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/altrix-precision-temperature-management-system-dwj (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/altrix-precision-temperature-management-system-dwj.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/altrix-precision-temperature-management-system-dwj
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.