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Terminated

HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

FDA Recall Z-2842-2016 · Posted None

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2016-08-26
Date Terminated2020-07-24
Product Quantity394 units

Reason for Recall

The handle can separate from the MRx housing due to breakage of mounts on the rear case.

Firm Action

Philips Healthcare issued customer an Urgent Medical Device Correction notification/Field Safety Notice on 11/19/14. The Urgent Medical Device Correction notification/Field Safety Notice FSN86100158A 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. You can continue to use your MRx prior to receiving the hardware upgrade. If one or both sides of the handle are found to have separated from the MRx housing, continue to treat your patient per existing protocols. Do not use the handle to carry the MRx. The MRx can be carried in another manner. For example, the MRx shoulder strap or bed rail hook can be used if available on the unit A hardware 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. Contact your local Philips representative or call 1-800-722-9377.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution. US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and 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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