ZOLL Medical Recalls
15 recalls on record · September 26, 2012 to March 19, 2025 · Medical Devices
Recalls by year
12
14
18
19
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: NA Product Descrip
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4)
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
March 19, 2025Medical DevicesFDA
ZOLL Medical Corporation recalls Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-
Hazard: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
July 17, 2024Medical DevicesFDA
Zoll Medical Corporation recalls ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating l
Hazard: G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
June 26, 2024Medical DevicesFDA
ZOLL Medical Corporation recalls ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG
Hazard: Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy
July 10, 2019Medical DevicesFDA
ZOLL Medical Corporation recalls ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of
Hazard: There is a potential for the device to fail to deliver energy to the patient.
March 21, 2018Medical DevicesFDA
ZOLL Medical Corporation recalls OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 108
Hazard: A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.
March 7, 2018Medical DevicesFDA
ZOLL Medical Corporation recalls 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in
Hazard: A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
April 9, 2014Medical DevicesFDA
ZOLL Medical Corporation recalls Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or
Hazard: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
September 26, 2012Medical DevicesFDA
ZOLL Medical Corporation recalls Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for
Hazard: Shipped with incorrect software