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X SERIES
Zoll Medical Corporation · Model 601-2221001-01 · UDI-DI 00847946061395
MKJ
Prescription
10
510(k) clearances
270,708
Adverse events (4,538 deaths)
336
Recalls
68
Facilities
Description
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, SPO2, ETCO2, DMST
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-27 | HeartSine Technologies Ltd | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| 2026-07-27 | 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 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.