HeartSine samaritan PAD (Public Access Defibrillator):… recallZ-1141-2024 · HeartSine Technologies Ltd · initiated Feb 14, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from HeartSine Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-1141-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 14, 2024
- Posted by the FDA
- Feb 15, 2024
- Recalling firm
- HeartSine Technologies Ltd
- Quantity
- 12
- Product code
- MKJ
- 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 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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- HeartSine Samaritan PAD 350P SAM 350PHeartsine Technologies Ltd · Automated external defibrillators (non-wearable)3 recalls2 deaths83 reports
- HeartSine Samaritan PAD 450P SAM450PHeartsine Technologies Ltd · Automated external defibrillators (non-wearable)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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