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ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family… recallZ-2324-2024 · Zoll Medical Corporation · initiated May 31, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zoll Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Use error

What the company is doing

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.

Recall details

Recall number
Z-2324-2024
Status
Open, Classified
Initiated by the company
May 31, 2024
Posted by the FDA
Jul 10, 2024
Recalling firm
Zoll Medical Corporation
Quantity
14885
Product code
MKJ
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

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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