ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating l

FDA device recall Z-2324-2024 · posted 2024-07-10 · Open, Classified

Recall details

Recalling firm

Zoll Medical Corporation

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

Action taken

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.

Root cause

Use error

Status

Open, Classified

Product code

MKJ

Quantity affected

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

Date initiated

2024-05-31

Date posted

2024-07-10

Location

Deerfield, WI