Z-1141-2024Class II

HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10...

Name: Z-1141-2024 HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10...
Creator: HeartSine Technologies Ltd
Published: 2024-02-14
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2024-02-14 / Open, Classified / root cause: manufacturing process

FDA source

HeartSine Technologies Ltd began a recall of 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... on 2024-02-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1141-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-14
Posted: 2024-02-15
Recalling firm: HeartSine Technologies Ltd
Product: 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
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/14/24, correction notices were mailed to customers who were asked to do the following: 1) Maintain awareness of this communication internally until the required action has been completed within your facility. 2) Inform the recalling firm if any of the subject devices were distributed to other organizations. The firm will work with you to ensure recipients are notified appropriately. 3) Complete and return the acknowledgment form to [email protected] Upon receipt of the acknowledgment form, the firm will provide instructions on next steps including device replacement. If you have any questions or concerns, please contact the firm's Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday - Friday or by email at [email protected].
Quantity in commerce: 12
Distribution: Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1141-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-15

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)