Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to Recalled by Heartsine Technologies, Limited Due to Certain Samaritan 300/300P PAD devices may experience one...

Date: September 13, 2012
Company: Heartsine Technologies, Limited
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Heartsine Technologies, Limited directly.

Affected Products

HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation

Quantity: 81,982 in total

Why Was This Recalled?

Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Heartsine Technologies, Limited

Heartsine Technologies, Limited has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report