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Terminated

Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A

FDA Recall Z-0848-05 · Posted 2005-05-17

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-04-29
Date Terminated2010-09-14
Product Quantity5125 units

Reason for Recall

The device may disarm and not deliver shock when performing a Synchronized Cardioversion

Firm Action

Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.

Root Cause

Software design

Distribution Pattern

Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen

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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