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U.S. Department of Health and Human Services

Class 2 Device Recall Altrix Precision Temperature Management System

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  Class 2 Device Recall Altrix Precision Temperature Management System see related information
Date Initiated by Firm September 06, 2018
Create Date October 24, 2018
Recall Status1 Terminated 3 on April 13, 2020
Recall Number Z-0235-2019
Recall Event ID 81103
510(K)Number K180834  K152266  
Product Classification System, thermal regulating - Product Code DWJ
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.
Code Information 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  
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Victoria Haney
269-389-8306
Manufacturer 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
FDA Determined
Cause 2		 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 Support by calling +1 800 327 0770 and selecting opt 2.
Quantity in Commerce 389 units
Distribution Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = STRYKER MEDICAL
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