ZOLL Medical Corporation

FDA Regulatory Profile

Summary

Total Recalls
15 (1 Class I)
510(k) Clearances
30
Inspections
24
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-1319-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (February 13, 2025
Z-1317-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSFebruary 13, 2025
Z-1316-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (February 13, 2025
Z-1323-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version:February 13, 2025
Z-1318-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSFebruary 13, 2025
Z-1320-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (February 13, 2025
Z-1322-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01February 13, 2025
Z-1321-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version:February 13, 2025
Z-2324-2024Class IIZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is desMay 31, 2024
Z-2130-2024Class IZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick April 30, 2024
Z-1931-2019Class IIZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defJune 12, 2019
Z-0977-2018Class IIOneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single August 4, 2017
Z-0812-2018Class II731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are June 30, 2017
Z-1311-2014Class IIZoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software VerMarch 5, 2014
Z-2401-2012Class IIZoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified meAugust 16, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K233486731 Series VentilatorDecember 13, 2024
K202375ZOLL Propaq MMarch 9, 2021
K180482ZOLL Propaq MNovember 30, 2018
K172653Power InfuserJuly 18, 2018
K162832731 Series VentilatorsAugust 2, 2017
K170533Model 330 Multifunction AspiratorApril 18, 2017
K142915ZOLL X SeriesDecember 3, 2014
K141774ZOLL X SERIESNovember 19, 2014
K140502ZOLL E SERIES ALSNovember 6, 2014
K132488ZOLL CODE WRITERApril 3, 2014
K131919ZOLL EPCR IOSDecember 17, 2013
K122839ZOLL SUREPOWER SINGLE BAY CHARGERDecember 13, 2012
K121865ZOLL RESCUENET 12-LEADNovember 20, 2012
K121367ZOLL PROPAQ XMJune 21, 2012
K110978ONESTEP PEDIATRIC MFE'SMay 13, 2011
K103473ZOLL RESCUENET EPCR MODEL RESCUENET EPCRMay 13, 2011
K110742ONESTEP ADULT MULTI-FUNCTION ELECTRODEApril 13, 2011
K110526ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATEMarch 25, 2011
K091561ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASESeptember 23, 2010
K090736POWER INFUSER, MODEL M100B-3AMay 20, 2009