Reported May 22, 2024 · Ongoing
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
HeartSine Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartSine Technologies Ltd · 207 Airport Road West · Belfast, N/A · N/A
Is this the product you have?
- HeartSine samaritan PAD (Public Access Defibrillator)
- Type
SAM 350PSAM 360PSAM 450P
- Lot codes and dates
- UDI-DI5060167125379, 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
16D16E16G17D17E17G18D18E18G19D19E19G20D20E20G21D21E21G22D22E22G23D23E23G24D24E24G
- Serial NumbersThe 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
- Example16D00001234
- Amount recalled
- 183,248
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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