HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-
Summary
The FDA issued a Class II for HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/35 by HeartSine Technologies Ltd. Reason: Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration result.
Details
Source
Device Recall
External ID
Z-1141-2024
Action Date
2024-02-21
Status
Ongoing
Category
device
Product Description
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
Lot/Code Info: Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671, 05060167127670, +M727SAM350P0/$$+7/17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391; SAM 360P/05060167127687, 05060167127311,5060167122927/21E91049810, 23E90001379, 23E90010409; SAM 450P/05060167129773, +M727SAM450P0/$$+7, +M727SAM450P0/$$+7/17G00001893, 18G00001553; SAM 500P/05060167122453/22B91071233
Quantity Affected: 12
Reason for Recall
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
Distribution
Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-14
Company
Belfast, N/A
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
HeartSine Technologies Ltd has 6 FDA actions in our database, including 6 recalls.
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 (HeartSine Technologies Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HeartSine Technologies Ltd have FDA actions?
HeartSine Technologies Ltd has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1141-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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