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 c
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 389 units of its Altrix Precision Temperature Management System Model 8001, a device used for circulating temperature-controlled warm or cold fluids. The recalled units were manufactured between October 4, 2016 and June 30, 2017 and were distributed nationwide in the US as well as in Australia, Canada, the Netherlands, Switzerland, and the United Kingdom. The specific model numbers and serial numbers affected by this recall are listed in the distribution materials.
The recall addresses three issues: users may experience frequent alarms due to patient temperature deviations beyond 0.5°C while in Automatic mode, users may encounter a Remove from Use code 9 (RFU 9) fault condition related to unintended flow alarms, and users may experience a code RFU 27 fault condition caused by mechanical interference between the device fan and filter. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom Quantity: 389 units Lot/code info: 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 201611000100140 201611000100141 201609000500005 201609000500001 201609000500002 201609000500003 201609000500004 201609000500006 201609000500007 201609000500008 201609000500009 201609000500010 201609000500011 201609000500012 201609000500013 201609000500039 201609000500050 201610000500062 20161000050006
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.