Zoll Medical Corporation: ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ven

Hazard

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

Details from the source

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: 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 Quantity: 14885 Lot/code info: 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

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.