ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating l
Summary
The FDA issued a Class II for ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibr by Zoll Medical Corporation. Reason: 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 shi.
Details
Source
Device Recall
External ID
Z-2324-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
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
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
Quantity Affected: 14885
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-31
Company
Deerfield, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zoll Medical Corporation has 11 FDA actions in our database, including 10 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zoll Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zoll Medical Corporation have FDA actions?
Zoll Medical Corporation has 11 FDA actions in our database, including 10 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2324-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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