Reported Nov 7, 2012 · Terminated

HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753;…

Heartsine Technologies, Limited

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Heartsine Technologies, Limited · 203 Airport Road West · Belfast, N/A · N/A

Is this the product you have?

  • HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000
  • to 10C00210106 Product UsageSamaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest
  • who are exhibiting the following signsUnconsciousness Not breathing Without circulation
Lot codes and dates
    • Serial numbers 0400000501 to 0700032917
    • 08A00035000 to 10A0070753
    • 10C00200000 to 10C00210106
Amount recalled
81,982 in total

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 10, 2015 · Data as of Sep 19, 6:50 PM UTC

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