Z-1820-2024Class II

HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

Name: Z-1820-2024 HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Creator: HeartSine Technologies Ltd
Published: 2024-04-08
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2024-04-08 / Open, Classified / root cause: manufacturing process

FDA source

HeartSine Technologies Ltd began a recall of HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P on 2024-04-08. FDA classified it as Class II and gives the reason as "Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be...". 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-1820-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-08
Posted: 2024-05-14
Recalling firm: HeartSine Technologies Ltd
Product: HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/08/24 Stryker sent correction notices to customers informing them of the following: 1) Follow instructions to power cycle affected devices: a) Check the expiration date on the Pad-Pak and if passed, do not use and replace the expired Pad-Pak. b) Place the affected device face up on a flat surface and slide the Pad-Pak into the affected device until you hear the "double click." c) Verify that the green Status indicator is blinking to indicate the initial self-test routine has been performed and the device is ready for use. d) Press On/Off button. c) Listen for, but do not follow, voice prompts. -If you do not hear a prompt, contact your Authorized Distributor or HeartSine Technologies Technical Support at: [email protected] -If you hear prompt "Adult patient" and/or "Call for medical assistance", no further action is needed. d) Press On/Off button. If you have not heard a warning message and the status indicator continues to flash green, the device is ready for use. e) Carry out check once every three months and maintain awareness. f) Audio issue will not cause a warning message, but if any other warning messages are played, or you see a red flashing status indicator, please refer to User Manual (General Troubleshooting). 2) Complete/return the response form to [email protected]. 3) If further distributed, email to [email protected]. Stryker will work with you to ensure recipients are notified. 4) If you have any questions or concerns, contact Customer Support at +44 28 9093 9400, 9A.M. to 5P.M. (GMT), or by email at [email protected]. On 3/17/2025, additional correction notices were sent and in addition customers were informed: - Keep track of the total number of impacted devices as well as the number of devices that do not provide audio prompts (if any). - If unable to complete this check every 3 months, please reach out to [email protected] for further alternative solutions that may be applied.
Quantity in commerce: 183,248
Distribution: US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
Product codes and lots: UDI-DI: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 5060167122514, 5060167121371, 5060167120671, 5060167121630, 5060167128042, 5060167120701, 5060167128080, 5060167120695, 5060167120725, 5060167120718, 5060167120909, 5060167120916, 5060167122071, 5060167120893. Devices affected by this notification begin with the following prefixes and device codes: 16D, 16E, 16G, 17D, 17E, 17G, 18D, 18E, 18G, 19D, 19E, 19G, 20D, 20E, 20G, 21D, 21E, 21G, 22D, 22E, 22G, 23D, 23E, 23G, 24D, 24E, 24G Serial Numbers: The prefix (device identifier) consists of the manufacturing date (YY) and the device model (B, D, E, G, or H) and an 8-digit serial number string. Example: 16D00001234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1820-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1820-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-14

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)