Home / Recalls / Zoll Medical Corporation / Z-2324-2024

Z-2324-2024 Class II Ongoing

Recalled by Zoll Medical Corporation — Deerfield, WI

Recall Details

Product Type
Devices
Report Date
July 17, 2024
Initiation Date
May 31, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14885

Product Description

ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-00A-TSO G5S-00C G5S-01A G5S-02A G5S-02C G5S-02-L G5S-04A G5S-05A G5S-05C G5S-06A G5S-06C G5S-08A G5S-08C G5S-10A G5S-10C G5S-11A G5S-11C G5S-12C G5S-13A G5S-14A G5S-15A G5S-17A G5S-17C G5S-19A G5S-23C G5S-29A G5S-29C G5S-31A G5S-31A-SJA G5S-31C-SJA G5S-36A G5S-37A G5S-41A G5S-41C G5S-80A G5S-80A-TSO G5S-80C G5S-80-L G5S-82A G5S-82C G5S-83C G5S-90C

Reason for Recall

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

Distribution Pattern

Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR

Code Information

GTIN: 00812394021239 00812394021277 00812394021284 00812394021413 00812394022779 00847946038182 00847946038199 00847946038243 00847946038250 00847946038304 00847946038328 00847946038335 00847946038342 00847946038359 00847946038380 00847946038397 00847946038403 00847946038410 00847946038434 00847946038441 00847946038496 00847946038519 00847946038533 00847946038571 00847946038588 00847946038663 00847946038816 00847946038830 00847946039028 00847946039035 00847946039066 00847946039127 Serial Number Range: D00000276194-D00000343449

Other recalls by Zoll Medical Corporation

  • Z-1319-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A (February 13, 2025)
  • Z-1317-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A (February 13, 2025)
  • Z-1316-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A (February 13, 2025)
  • Z-1323-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A (February 13, 2025)
  • Z-1318-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A (February 13, 2025)
  • Z-1320-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S (February 13, 2025)
  • Z-1322-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S (February 13, 2025)
  • Z-1321-2025 Class II — Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C (February 13, 2025)
  • Z-2130-2024 Class I — ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operato (April 30, 2024)
  • Z-1931-2019 Class II — ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO uni (June 12, 2019)