HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
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…
Read the official notice →- Date
- 2024-05-22
- Country
- United States
- Brand
- HeartSine Technologies
- Product
- HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
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FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2024-02-21
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HeartSine Technologies Ltd recalls HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM…
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…
FDA · DeviceHeartSine Technologies LtdWorldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL,…Official notice → - 2023-07-19
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HeartSine Technologies Ltd recalls HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access…
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
FDA · DeviceHeartSine Technologies LtdWorldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI,…Official notice → - 2023-03-15
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HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic…
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
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