Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
FDA Recall Z-0278-2018 · Posted None
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Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMSX
Date Initiated2017-09-28
Date Terminated2018-10-12
Product Quantity20 units ( 18 domestic, 2 foreign)
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).
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
20 units affected. 18 domestic, 2 foreign.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K063375HEARTSTART MRX, MODELS M3535A OR M3536APhilips Medical Systems · 2007-01-11K062233HEARTSTART MRX MONITOR/DEFIBRILLATORPhilips Medical Systems North America, Inc. · 2006-11-22K061707HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONSPhilips Medical Systems · 2006-08-11K051134HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536APhilips Medical Systems · 2005-09-08K040404HEARTSTART MRX, MODEL M3535APhilips Medical Systems, Inc. · 2004-05-04K031187HEARTSTART MRX, MODEL M3535APhilips Medical Systems · 2003-08-27
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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