Official recall record
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-08
- Country of alert
- United Kingdom
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 5060167125379
- Brand on record
- HeartSine Technologies Ltd
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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