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Automated External Defibrillators (Non-Wearable)
FDA product code MKJ · Class 3 · Cardiovascular
4,017
Registered devices
270,708
Adverse events
336
Recalls
228
510(k) clearances
Devices with this code
M SERIES — Zoll Medical CorporationM SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationLIFEPAK 35 Monitor/Defibrillator — PHYSIO-CONTROL, INC.Powerheart G5 Semi Automatic AED — Zoll Medical CorporationE SERIES — Zoll Medical CorporationX SERIES — Zoll Medical CorporationX SERIES — Zoll Medical CorporationLIFEPAK® 12 defibrillator/monitor — PHYSIO-CONTROL, INC.M SERIES BIPHASIC — Zoll Medical CorporationX SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationLIFEPAK® 500 Automated External Defibrillator — PHYSIO-CONTROL, INC.PEDI PADZ — Zoll Medical CorporationLIFEPAK® 20 and LIFEPAK 20e defibrillator/monitors — PHYSIO-CONTROL, INC.Powerheart® AED G3 Plus Automatic AED — Cardiac Science CorporationX SERIES — Zoll Medical CorporationPowerheart G5 Automatic AED — Zoll Medical CorporationPowerheart® Adult Defibrillation Pads — Cardiac Science CorporationE SERIES — Zoll Medical CorporationE SERIES — Zoll Medical Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-27 | HeartSine Technologies Ltd | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| 2026-07-27 | HeartSine Technologies Ltd | Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. |
| 2026-04-13 | Physio-Control, Inc. | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was |
| 2026-01-21 | Physio-Control, Inc. | Due to pediatric defibrillator electrode delamination |
| 2025-09-18 | HeartSine Technologies Ltd | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-06-30 | HeartSine Technologies Ltd | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) |
| 2025-03-18 | Defibtech, LLC | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information |
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