FDA Medical Device Recalls (openFDA)
Heartsine Technologies, Limited: 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
- Recall number
- Z-0124-2013
- Recalling firm
- Heartsine Technologies, Limited
- 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
- Status
- Terminated
- Initiated
- 2012-09-13
- Posted
- 2012-10-27
- Terminated
- 2015-07-10
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
- 510(k) numbers
- ["K041067","K052465"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3004123209
- Firm city
- Belfast
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28