Z-0124-2013Class I

HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to...

Name: Z-0124-2013 HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to...
Creator: Heartsine Technologies, Limited
Published: 2012-09-13
License: https://open.fda.gov/license/

HeartSine Technologies Ltd / initiated 2012-09-13 / Terminated / root cause: design

FDA source

Heartsine Technologies, Limited began a recall of HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage... on 2012-09-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0124-2013
Classification: Class I
Status: Terminated
Initiated: 2012-09-13
Posted: 2012-10-27
Terminated: 2015-07-10
Recalling firm: HeartSine Technologies Ltd
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
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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
Root cause tag: design
FDA root cause: Device Design
Action: HeartSine sent an Urgent: Medical Device Recall dated September 2012 to all affected customers. The letter identifed the affected product, problem and actions to be taken. A response form was included with the letter to be completed by customers and returned to the recalling firm's representative. In addition, HeartSine is providing a software upgrade to bring all users up to a more recent version of the software. For questions call 1-877-877-0147 or your service representative.The company issued an additional press release on September 13, 2013 in a further attempt to reach out to end customers that had not yet responded to the companys efforts.
Quantity in commerce: 81,982 in total
Distribution: Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2013	Class I	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-26

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)