Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-
Summary
The FDA issued a Class II for Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully by HeartSine Technologies Ltd. Reason: Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no t.
Details
Source
Device Recall
External ID
Z-1217-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Lot/Code Info: REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080
Quantity Affected: 13
Reason for Recall
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Distribution
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
Belfast
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 137 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-1217-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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