Consumer Lawyers

Class I recall for HeartSine public-access defibrillator

In FDA REcalls on November 20, 2012 at 5:01 pm

The FDA has issued a highest-level class I recall [1] for some Samaritan model 300/300p public-access defibrillators (HeartSine Technologies) following release of the company’s “global-correction” letter in September that described the problem and its recommended fixes [2].

The defibrillators are at risk of premature battery depletion from intermittently turning on and off. “In addition and separately,” the company says, a glitch in the battery-management software could cause the unit to turn itself off. Either problem could keep it from delivering therapy when needed, the company states.

The recall applies to 300/300p units with serial numbers from 0400000501 to 0700032917, 08A00035000 to 10A0070753, and 10C00200000 to 10C00210106, manufactured from August 2004 through December 2010 with a seven-year warrantee.

 

http://www.theheart.org/article/1477523.do

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