Device recall: Philips HeartStart FRx AED.
FDA enforcement event 79343 is a device recall by Philips Electronics North America Corp. of Bothell, WA, initiated 14 Mar 2018 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 19 Aug 2020. Initiation: fda mandated. Philips Electronics North America Corp. has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Electronics North America Corp., Bothell, WA.
Reason for recall
"An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed."
Distribution
"Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1913-2018 | Philips HeartStart FRx AED. | Total for FRx and HS1 - 660,519 defibrillators | Class II | Terminated | 30 May 2018 |
| Z-1914-2018 | Philips HeartStart (HS1) Onsite/Home AED | Total for FRx and HS1 - 660,519 defibrillators | Class II | Terminated | 30 May 2018 |
Context
Other enforcement events for Philips Electronics North America Corp.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Oct 2018 | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected (81134) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.