HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5

FDA device recall Z-0963-2015 · posted 2015-01-13 · Terminated

Recall details

Recalling firm: Philips Medical Systems, Inc.
Reason for recall: Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Action taken: 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
Status: Terminated
Product code: MKJ
Quantity affected: 74,499 devices
Distribution: Worldwide Distribution - US Nationwide
Date initiated: 2014-11-19
Date posted: 2015-01-13
Date terminated: 2019-10-04
Location: Andover, MA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
HEARTSTART MRX, MODELS M3535A OR M3536A (K063375)	Philips Medical Systems	2007-01-11
HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233)	Philips Medical Systems North America, Inc.	2006-11-22
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707)	Philips Medical Systems	2006-08-11
HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134)	Philips Medical Systems	2005-09-08
HEARTSTART MRX, MODEL M3535A (K040404)	Philips Medical Systems, Inc.	2004-05-04
HEARTSTART MRX, MODEL M3535A (K031187)	Philips Medical Systems	2003-08-27