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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/Defibrillator see related information
Date Initiated by Firm September 28, 2017
Create Date December 21, 2017
Recall Status1 Terminated 3 on October 12, 2018
Recall Number Z-0278-2018
Recall Event ID 78698
510(K)Number K031187  K040404  K051134  K061707  K062233  K063375  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product Automated 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 Contact Gary 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
Action The 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 Commerce 20 units ( 18 domestic, 2 foreign)
Distribution 20 units affected. 18 domestic, 2 foreign.
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 = MSX and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = MSX and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = MSX and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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