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M SERIES
Zoll Medical Corporation · Model 40021521000163010 · UDI-DI 00847946006266
10
510(k) clearances
269,682
Adverse events (4,528 deaths)
335
Recalls
68
Facilities
Description
Defibrillator ,MAIN,EMTD-1,12LEAD,SPO2,NIBP,PACE,EL,RCD,SMR,CDMK,DC, DMST
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-27 | HeartSine Technologies Ltd | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| 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 conducted, and the i |
| 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 (labelling and instr |
| 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 (labelling and instr |
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