Home / Recalls / Heartsine Technologies, Limited / Z-0124-2013

Z-0124-2013 Class I Terminated

Recalled by Heartsine Technologies, Limited — Belfast, N/A

Recall Details

Product Type: Devices
Report Date: November 7, 2012
Initiation Date: September 13, 2012
Termination Date: July 10, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 81,982 in total

Product Description

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

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

Distribution Pattern

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.

Code Information

Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106