Philips North America, LLC recalls HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M35…

Recall date

February 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1417-2017

FDA classification

Class I

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RIC…

Why it was recalled

HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9