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 070003291708A00035000 to 10A007075310C00200000 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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