FDA Device recall Z-1820-2024
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
- FDA Device
- Class II
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class II recall of HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P by Heartsine Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1820-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Heartsine Technologies |
| Distribution | US |
Product
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Reason
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.
Identifiers
| code_info | UDI-DI: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 50601671…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1820-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.