Philips HeartStart FRx 861304 Automated External Defibrillator… — Class II medical device recall Z-0642-2013
Terminated recall by Philips Medical Systems North America Co. Phillips, reported 2013-01-16, distributed nationwide. Philips determined that it is important to clarify information in the Owner's Manual and keep customers inform
| Recall number | Z-0642-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems North America Co. Phillips, Bothell, WA, United States |
| Recall initiated | 2012-07-26 |
| Classified | 2013-01-04 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2020-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, MY |
| Quantity | 201,598 |
| Model numbers | 861304, 861305 |
Product
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Reason for recall
Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0642-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.