CLASS I Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
HeartSine Samaritan(R) 300/300P PAD devices recalled
Heartsine Technologies is recalling HeartSine Samaritan(R) 300/300P PAD devices, distributed nationwide in the US. The recall was initiated on 13 Sep 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0124-2013
- FDA event ID
- 63139
- Recalling firm
- Heartsine Technologies, Belfast, N/A
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Sep 2012
- FDA classified
- 26 Oct 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Sep 2012 | Recall initiated by company | |
| 26 Oct 2012 | Classified by FDA | +43 days |
| 7 Nov 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Is HeartSine Samaritan(R) 300/300P PAD devices recalled?
Yes. Heartsine Technologies recalled HeartSine Samaritan(R) 300/300P PAD devices on 13 Sep 2012. The recall is Class I and its status is Terminated. Recall number Z-0124-2013.
Why was it 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
Which lots are affected?
Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Heartsine Technologies
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartSine Pad-Pak recalled by HeartSine Technologies | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator), Type recalled | HeartSine Technologies | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator): Type recalled | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold recalled | HeartSine Technologies | Device Malfunction | Nationwide |
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