Class 2 Device Recall ZOLL

• Date Initiated by Firm: May 31, 2024
• Date Posted: July 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2324-2024
• Recall Event ID: 94792
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: 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
• 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
• Recalling Firm/ Manufacturer: Zoll Medical Corporation; 500 Burdick Pkwy; Deerfield WI 53531-9692
• Manufacturer 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
• FDA Determined Cause: Use error
• Action: Zoll Medical issued Urgent Corrective Distributor notification on 31-May-24 and consignees notification commenced 07-Jun-24 via email. Letter states reason for recall, health risk and action to take: Customers who have affected devices should immediately take the following steps: (1) Alert G5 Semi-Automatic AED users of this problem. (2) Locate the affected devices. (3) Remove the protective film in accordance with Appendix A. (4) Respond to ZOLL via the customer notification form acknowledging that the protective film has been removed. Technical support numbers 1 (800) 348-9011 or 1 (978) 421-9460 and are available to assist users with any aspect of this notice.
• Quantity in Commerce: 14885
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.