Recall Z-0235-2019 ยท DWJ System, Thermal Regulating
Stryker Medical Division of Stryker Corporation
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.
| Date | Sep 6, 2018 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | Stryker notified accounts by letter on 9/6/18 via Fed'X advising of the problem, steps to be taken: 1.Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2.Return the enclosed business reply form to confirm receipt of this notification by fax 269 488 8691 or email productfieldaction@stryker.com. 3.Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Altrix unit. 4.If you have questions regarding the safe continued use of your Altrix unit, please contact Tech Suppor |
| Quantity | 389 units |
| Distribution | Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom |
| FDA record | Open on fda.gov |