Z-1217-2023Class II

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM...

Name: Z-1217-2023 Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM...
Creator: HeartSine Technologies Ltd
Published: 2023-02-01
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2023-02-01 / Open, Classified / root cause: manufacturing process

FDA source

HeartSine Technologies Ltd began a recall of Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor on 2023-02-01. FDA classified it as Class II and gives the reason as "Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy". 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-1217-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-03
Recalling firm: HeartSine Technologies Ltd
Product: Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/1/23, correction notices were mailed to customers who were asked to do the following: 1) Confirm that the device has incorrect language voice prompts by using the Device Language Check. 2) If the device is found to have incorrect language configuration, remove it form use. The recalling firm will provide a replacement device. 3) Inform the recalling firm of any of the subject devices have been distributed to other organizations. 4) Complete and return the acknowledgement form to [email protected] If you have questions or concerns contact 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]. Language Check: 1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a "double click". 2) Verify the green status indicator is blinking. 3) Press the On/Off button. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language. 4) Press On/Off button to turn off the device.
Quantity in commerce: 13
Distribution: US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1217-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1217-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-03

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)