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Terminated

HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MRxE). Note: M3536JIMRxE was sold to Japan only. The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED).

FDA Recall Z-1795-2009 · Posted 2009-07-24

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product Codemkj
Date Initiated2009-07-07
Date Terminated2013-02-19
Product Quantity11,579 units

Reason for Recall

External transport use environments, the mechanical/electrical connection between the pads therapy cable including pads/CPR cable and the MRx/MRxE may wear at an increased rate ultimately prevent the device from sensing that the pads therapy cable is connected, or, cause the device to inappropriately identify external paddles or internal paddles when the pads therapy cable is connected

Firm Action

Philips Healthcare issued an "Urgent - Voluntary Medical Device Correction" notice dated July 2009 providing information on the affected device, namely, how to identify the affected devices and instructions on actions to be taken. Consignees are asked to contact their local Philips representative to confirm receipt of the recall letter and to arrange for service. Contact Philips Healthcare for further questions at 1-800-722-9377.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- United States, Afghanistan, Albania, Australia, Austria, Bahrain, Brazil, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libyan Arab Jamaica, Lithuania, Netherlands, New Caldonia, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031187HEARTSTART 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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