HeartSine samaritan public access defibrillators may not deliver shocks properly
HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.
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: Risk-of-harm product: a defibrillator that may fail to deliver a shock when needed, with no injury reported in the source.
Plain-English summary
The HeartSine samaritan PAD (Public Access Defibrillator), models SAM 350P, SAM 360P and SAM 450P, is being recalled. The action covers 190,516 units, identified by the item numbers, UDI-DI codes and serial numbers in the recall notice.
The stated reason is that, due to a component manufacturing issue, the automated external defibrillator may not function properly to deliver shocks. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States across Alaska, Alabama and Arkansas among other states.
Owners should identify affected units using the item numbers, UDI-DI codes and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
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
- Affected units
- 190,516
Distribution
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