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U.S. Department of Health and Human Services

Class 1 Device Recall HeartSine Samaritan(R) 300/300P PAD devices

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 Class 1 Recall
HeartSine Samaritan(R) 300/300P PAD devices
see related information
Date Posted October 27, 2012
Recall Status1 Open
Recall Number Z-0124-2013
Recall Event ID 63139
Premarket Notification
510(K) Numbers
K041067  K052465 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
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
Code Information Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Recalling Firm/
Manufacturer
Heartsine Technologies, Limited
203 Airport Road West
Belfast
Manufacturer 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 occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitt
FDA Determined
Cause 2
DESIGN: 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = HEARTSINE TECHNOLOGIES, INC.
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