FDA-Device2026-09-16Class IIPROCESSING DEFECT
HeartSine SAM 350P, 360P, and 450P defibrillators recalled for intermittent electrical fault
What this means
HeartSine Technologies has recalled certain models of the SAM 350P, SAM 360P, and SAM 450P public access defibrillators (PADs) due to a damaged membrane component that can cause an intermittent electrical fault. The fault could prevent the device from operating properly when needed in a cardiac emergency. Approximately 11,912 affected units have been identified by serial number.
- Check if your device serial number matches the recall list at the FDA website or contact HeartSine directly.
- Do not remove recalled devices from service until you have received replacement or repair instructions from HeartSine.
- Contact HeartSine Technologies or your equipment provider for a replacement or repair.
The agency's original wording
Hazard
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
Intended for
All ages (12 months and older)
Illnesses reported
None reported
Sold states
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Indonesia, ISRAEL, JAPAN, Malaysia, Netherlands, Philippines, POLAND, SINGAPORE, South Korea, Taiwan, Thailand and UNITED KINGDOM.
Affected count
11,912
Manufactured in
207 Airport Road West, Belfast, United Kingdom
Products
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 SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3120-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.