ClearanceBrief
Recall Z-0963-2015 ยท MKJ Automated External Defibrillators (Non-Wearable)

Philips Medical Systems, Inc.

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, advan

DateJan 13, 2015 (initiated Nov 19, 2014)
StatusTerminated
ReasonDevice may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Root causeSoftware design
ActionOn 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
Quantity74,499 devices
DistributionWorldwide Distribution - US Nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K031187HEARTSTART MRX, MODEL M3535A
Philips Medical Systems, Aug 27, 2003
K040404HEARTSTART MRX, MODEL M3535A
Philips Medical Systems, Inc., May 4, 2004
K051134HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
Philips Medical Systems, Sep 8, 2005
K061707HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
Philips Medical Systems, Aug 11, 2006
K062233HEARTSTART MRX MONITOR/DEFIBRILLATOR
Philips Medical Systems North America, Inc., Nov 22, 2006
K063375HEARTSTART MRX, MODELS M3535A OR M3536A
Philips Medical Systems, Jan 11, 2007