HeartSine Public Access Defibrillators Recalled for Voice Prompt Manufacturing Defect
Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.
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 Class II recall affects critical emergency medical equipment. The manufacturing defect prevents voice prompts during use—a key instructional component—which could cause delayed or absent therapy during cardiac emergencies. No injuries or illnesses have been reported, but the hazard is significant for a high-risk-of-harm medical device.
Plain-English summary
HeartSine Technologies Ltd is recalling HeartSine samaritan PAD defibrillators, models SAM 350P, SAM 360P, and SAM 450P, due to a manufacturing defect affecting voice prompt delivery.
The affected devices may not deliver instructional voice prompts during use. While visual instructional icons remain present, the absence of voice guidance could prevent proper operation during cardiac emergencies and potentially lead to delayed or absent therapy.
Approximately 183,248 units have been distributed nationwide across the United States. Affected device identification numbers and serial number prefixes are available from the FDA to help identify recalled units.
The recalled product
- Product
- HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
- Manufacturer
- HeartSine Technologies Ltd
- Category
- Medical Device — Defibrillator
- Hazard
- device-malfunction
- voice-prompt-failure
- delayed-therapy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 5060167125379
- 5060167120688
- 5060167125720
- 5060167128066
- 5060167122330
- 5060167122491
- M727SAM450P
- 5060167122514
- 5060167121371
- 5060167120671
- 5060167121630
- 5060167128042
- 5060167120701
- 5060167128080
- 5060167120695
- 5060167120725
- 5060167120718
- 5060167120909
- 5060167120916
- 5060167122071
Distribution
Distributed nationwide across the United States.
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