Date Submitted
1/28/2019 1:09 PM
Recall Issued on
3/14/2018
Instructions
Class 2 Device Recall Philips HeartStart FRx AED
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.
More Information
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162082