HeartSine recalls specific Samaritan PAD defibrillators with potential for incorrect CPR prompts and shock intervals, risking delayed life-saving therapy. Affected units have unique model numbers and were sold in the US, UK, and Japan.
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.
HeartSine is recalling certain public access defibrillators that may give incorrect CPR instructions and shock intervals, which could delay life-saving treatment during cardiac emergencies. This recall affects specific models sold in the US, UK, and Japan.
The defibrillators were shipped in test mode, causing them to prompt CPR for 5 seconds instead of the correct duration. If a shockable heart rhythm is detected, the device may instruct users to deliver shocks every 5 seconds, potentially delaying critical therapy.
Public access defibrillators used by first responders, hospitals, and emergency services in the US, UK, and Japan are most at risk. Anyone with the listed model numbers should check if their device is affected.
Check for model numbers like SAM 350P/350-UNIT-US-10 or SAM 360P/360-STR-JA-10. The device was sold in the US, UK, and Japan between 2008 and 2017 based on the serial numbers.
Look for model numbers such as SAM 350P/350-UNIT-US-10 or SAM 360P/360-STR-JA-10 on the device label.
Reach out to HeartSine Technologies Ltd for verification of your device's model and instructions on next steps.
The defibrillators were shipped in test configuration, causing incorrect CPR prompts and shock intervals that could delay life-saving therapy.
Specific models including SAM 350P/350-UNIT-US-10, SAM 360P/360-STR-JA-10, and SAM 450P/450-UNIT-US-08 were sold in the US, UK, and Japan between 2008 and 2017.
No, but you should check if your device is affected and contact HeartSine for guidance.
We’ve drafted a message you can send HeartSine to request your refund or repair — edit it as you like.
Subject: Recall Z-1141-2024 — HeartSine HeartSine Hello, I own a HeartSine that is covered by recall Z-1141-2024 from HeartSine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
