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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart MRx Monitor/Defibrillator

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 Class 2 Device Recall HeartStart MRx Monitor/Defibrillatorsee related information
Date Initiated by FirmSeptember 28, 2017
Create DateDecember 21, 2017
Recall Status1 Terminated 3 on October 12, 2018
Recall NumberZ-0278-2018
Recall Event ID 78698
510(K)NumberK031187 K040404 K051134 K061707 K062233 K063375 
Product Classification System,network and communication,physiological monitors - Product Code MSX
ProductAutomated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Code Information 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactGary Gilliam
978-659-3000
Manufacturer Reason
for Recall		Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe Philips Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.
Quantity in Commerce20 units ( 18 domestic, 2 foreign)
Distribution20 units affected. 18 domestic, 2 foreign.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MSX
510(K)s with Product Code = MSX
510(K)s with Product Code = MSX
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