HeartSine SAM Public Access Defibrillators Recalled for Damaged Membrane Tail
HeartSine Technologies is recalling SAM 350P, 360P, and 450P defibrillators due to a damaged membrane tail that causes intermittent faults.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device intended for life-saving use in cardiac arrest. The defect causes an intermittent fault, which poses a risk of harm if the device fails during an emergency, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
HeartSine Technologies Ltd is recalling approximately 11,912 units of HeartSine SAM 350P, SAM 360P, and SAM 450P Public Access Defibrillators (PADs). The recall covers specific serial numbers and UDI-DI codes for devices distributed in the United States and internationally, including Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, Israel, Japan, Malaysia, Netherlands, Philippines, Poland, Singapore, South Korea, Taiwan, Thailand, and the United Kingdom.
The recall is being conducted due to a damaged, or over-stretched, membrane tail that causes an intermittent fault in the device. These defibrillators are indicated for use on victims of cardiac arrest who are unconscious, not breathing, and without circulation. The devices are intended for use on patients greater than 8 years old or over 55 lbs (25 kg) when used with adult pads, and for children between 1 and 8 years of age or up to 55 lbs (25 kg) when used with pediatric pads.
Consumers and facilities with these devices should check their serial numbers against the list provided in the official recall notice. If a device is affected, users should stop using it and contact HeartSine Technologies for instructions on repair or replacement.
The recalled product
- Product
- HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine…
- Manufacturer
- HeartSine Technologies Ltd
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 11,912
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 (1)
- 350P US Device
Distribution
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