FDA Alerts

Class 1 Recall: HeartSine Samaritan Public Access Defibrillator 300/300P

The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. Certain Samaritan® 300/300P PAD devices have been found to intermittently turn on and off,

Thu Sep 13 2012By Other Author

The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. 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.

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details.
I Agree