HeartSine Samaritan — Class I medical device recall Z-0124-2013

Terminated recall by Heartsine Technologies, Limited, reported 2012-11-07, distributed nationwide. Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affec

Recall number	`Z-0124-2013`
Product type	Medical device
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Heartsine Technologies, Limited, Belfast, N/A, United Kingdom
Recall initiated	2012-09-13
Classified	2012-10-26
Reported by FDA	2012-11-07
Terminated	2015-07-10
Distributed	Nationwide (US)
Quantity	81,982 in
Serial numbers	`0400000501`, `0700032917`, `08A00035000`, `10A0070753`, `10C00200000`, `10C00210106`

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0124-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.