FDA has issued a class I recall for certain HeartSine Samaritan public access defibrillators, according to a recall notice.
Certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.
Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:
- 0400000501 to 0700032917
- 08A00035000 to 10A0070753
- 10C00200000 to 10C00210106
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