Automated External Defibrillators recalled due to shock delivery malfunction
HeartSine SAM 350P, 360P, and 450P automated external defibrillators may fail to deliver electrical shocks due to a component manufacturing defect. Approximately 190,516 units are affected worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a life-critical medical device with a component defect that may prevent its core function (shock delivery). While no injuries or deaths have been reported in the source text, the potential for serious harm is significant given the device's role in cardiac emergency response. Per the rubric, risk-of-harm medical devices where injury has not yet been reported score as High.
Plain-English summary
This is an FDA Class II recall of HeartSine SAM 350P, 360P, and 450P automated external defibrillators (public access defibrillators). The devices are being recalled due to a component manufacturing issue that may prevent them from functioning properly and delivering electrical shocks to patients in cardiac arrest.
The affected devices include approximately 190,516 units distributed worldwide, including throughout the United States and in multiple countries including Canada, Japan, the United Kingdom, Australia, Argentina, Brazil, Chile, Colombia, and others.
According to the FDA, the hazard is a manufacturing defect in a component that could result in the device not delivering shocks when activated during a medical emergency. No injuries or illnesses have been reported in connection with this recall, though the potential for serious harm exists if an affected device is used in a cardiac emergency and fails to deliver therapy.
Consumers and facilities with affected AED units should immediately stop using the recalled devices and contact HeartSine Technologies Ltd for instructions regarding replacement or repair.
The recalled product
- Product
- HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
- Manufacturer
- HeartSine Technologies Ltd
- Hazard
- shock-delivery-failure
- device-malfunction
Distribution
Distributed nationwide across the United States.
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