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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Philips Electronics North America
- Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483…
FDA Device · Class II · 2018-12-26 · Philips Electronics North America - IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals…
FDA Device · Class II · 2018-12-19 · Philips Electronics North America - Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventric…
FDA Device · Class II · 2018-10-24 · Philips Electronics North America - INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America
All Philips Electronics North America recalls
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.