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Terminated

HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

FDA Recall Z-0963-2015 · Posted 2015-01-13

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-11-19
Date Terminated2019-10-04
Product Quantity74,499 devices

Reason for Recall

Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.

Firm Action

On November 19, 2014, Philips notified consignees of the recall via letter. The 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. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US Nationwide

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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