FDA Device recall Z-1913-2018

Philips HeartStart FRx AED

FDA Device
Class II
terminated
Published 2018-05-30

On 2018-05-30 the FDA classified a Class II recall of Philips HeartStart FRx AED by Philips Electronics North America, citing an issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1913-2018
Classification	Class II
Status	terminated
Initiated	2018-03-14
Published	2018-05-30
Last updated	2026-09-13 11:54 UTC
Company	Philips Electronics North America
Distribution	US

Product

Philips HeartStart FRx AED.

Reason

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

Identifiers

code_info	Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd ch… 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.

code_info

Manufactured between September 2002 and February 2013. The year of manufacture can be identified by the 2nd and 3rd ch…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1913-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.