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.
- Recall Initiated
- September 6, 2018
- Terminated
- April 13, 2020
- Recall Number
- Z-0235-2019
- Quantity
- 389 units
- Firm Location
- Portage, MI
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
Distribution
Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom
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 201610000500066 201610000500067 201610000500075 201609000500014 201611000500053 201611000500091 201611000500097 201611000500098 201611000500099 201611000500100 201611000500062 201611000500055 201611000500056 201611000500057 201611000500060 201611000500061 201611000500093 201611000500063 201611000500096 201610000500072 201610000500063 201610000500073 201610000500074 201703000500001 201703000500003 201703000500004 201703000500021 201703000500025 201703000500027 201610000500069 201610000500070 201610000500076 Serial Numbers: Stryker Owned 201612000100116 201612000100118 201612000100122 201701000100006 201701000100101 201701000100120 201612000100024 201701000100123 201612000100117 201612000100119 201612000100121 201612000100137 201612000100138 201612000100002 201612000100123 201612000100124 201701000100139 201612000100101 201612000100130 201701000100080 201701000100081 201701000100146 201701000100129 201701000100143 201701000100125 201701000100087 201701000100117 201612000100120 201701000100082 201701000100096 201701000100114 201701000100097 201701000100098 201701000100106 201701000100109 201701000100112 201701000100116 201701000100118 201701000100092 201701000100088 201701000100001 201701000100002 201701000100005 201701000100007 201701000100010 201701000100022 201701000100023 201701000100103 201701000100105 201702000100107 201702000100120 201612000100135 201701000100078 201702000100042 201702000100048 201702000100043 201702000100117 201702000100054 201702000100063 201702000100083 201702000100066 201702000100081 201702000100115 201702000100118 201703000100078 201703000100079 201702000100119 201702000100065 201702000100074 201702000100082 201702000100056 201702000100085 201702000100078 201702000100084 201611000500054 201612000100033 201703000100072 201703000100080 201704000400002 201701000100124 201701000100121 201701000100111 201702000100046 201703000100077 201702000100079
Root 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.