MASSDEVICE ON CALL — Medtech giant Philips Healthcare (NYSE:PHG) got renewed attention for its troubled HeartStart automated external defibrillators after the FDA this week issued a new warning letter over potentially faulty electrical components.
The recall, initially launched in September 2012, affects some 700,000 devices, according to the FDA notice.
The federal watchdog agency asked that healthcare providers keep their HeartStart machines in service until replacements are provided, even if the machines in question report errors during diagnostics.
"Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator," FDA Center for Devices & Radiological Health Office of Compliance director Steve Silverman said in prepared remarks.
The HeartStart troubles extend at least as far back as 2009, when Philips recalled about 5,400 AEDs over a microchip failure.
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