HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- HeartSine Technologies Ltd
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1820-2024
Related Recalls
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
HeartSine Technologies
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
HeartSine Technologies
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
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.