medical Class II Updated 2018-05-30

Philips Electronics North America Corp. recalls Philips HeartStart FRx AED.

Recalled Product

Philips HeartStart FRx AED.


Hazard / Issue

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd characters in the serial number on the back of the AED in the following ranges: Home/Onsite: A02x-xxxxx through A13B-xxxxx; FRx: B04x-xxxxx through B13B-xxxxx NOTE: If the device was manufactured in 2013 and the 4th digit is the letter "C" or later (D, E, F...), it is not covered by the recall (i.e. A13G-02375). In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. In that case, a notification was not sent. Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm.
View official government recall

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