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FDA slaps HeartSine with Class I recall

Tue, 11/20/2012 - 10:45am
Mass Device

HeartSine's recall of Samaritan defibrillators gets Class I status from the FDA over concerns that battery defects could lead to patient injury or death.

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The FDA gave HeartSine's Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death.

The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects.

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