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Terminated

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 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-0489-2018 · Posted 2018-02-08

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2017-07-12
Date Terminated2020-05-27
Product Quantity71 units

Reason for Recall

Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.

Firm Action

Philips Healthcare sent an Urgent Medical Device Correction Notification/Field Safety Notice letter dated June, 2017 to their customers. The letter identified the affected product, problem, hazard involved and actions to be taken. Philips is requesting that customers report if their device fails to function as intended. Philips will contact all customers for device replacement once parts are available. If you need further information or support concerning this action, please contact your local Philips representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062233HEARTSTART 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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