Philips HeartStart Home and OnSite — Class II medical device recall Z-1232-2014
Terminated recall by Philips Medical Systems North America Inc., reported 2014-03-26, distributed nationwide. Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or
| Recall number | Z-1232-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems North America Inc., Bothell, WA, United States |
| Recall initiated | 2014-02-06 |
| Classified | 2014-03-19 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Model numbers | M5066A, M5067A, M5068A |
Product
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
Reason for recall
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Machine access
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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.