Recall Z-0235-2019
Stryker Medical Division of Stryker Corporation · initiated September 6, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model numbers/ UDI: 8001000001 07613327277555; 8001000003 07613327277562; 8001000008 07613327277630; 8001000015 07613327277722; 8001000016 07613327277586; 8001000017 07613327277609; 8001000018 07613327277678; 8001000019 07613327277623; 8001000023 07613327277777 Altrix model 8001 units manufactured between October 4, 2016 and June 30, 2017: Serial Numbers: US: 201612000100044 201612000100034 201612000100126 201612000100127 201612000100129 201612000100134 201612000100136 201612000100003 201612000100004 201612000100005 201612000100007 201612000100009 201612000100111 201612000100112 201702000100045 201702000100101 201702000100102 201702000100103 201702000100104 201702000100108 201702000100110 201703000100074 201702000100116 201701000100142 201702000100051 201702000100105 201612000100106 Serial Numbers: OUS 201609000500040 201609000500041 201609000500042 201609000500043 201701000500049 201701000500050 201611000100095 201611000100094 201611000100096 201611000100097 201611000100126 201611000100098 201611000100118 201611000100119 201611000100120 201611000100121 201611000100122 201611000100123 201611000100124 201611000100125 201611000100127 201611000100137 201611000100138 201611000100139…
Reason for recall
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
FDA-determined cause: Software design
Action taken
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 Support by calling +1 800 327 0770 and selecting opt 2.
Details
- Recall number
- Z-0235-2019
- Initiated
- September 6, 2018
- Terminated
- April 13, 2020
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 389 units
- Distribution
- Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom
- Recalling firm
- Stryker Medical Division of Stryker Corporation, Portage, MI