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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94792

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 31, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Zoll Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2324-2024
Recall number
Z-2324-2024
Initiated
May 31, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Zoll Medical Corporation
Quantity
14885

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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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

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

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