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

FDA device recall Z-0124-2013 · posted 2012-10-27 · Terminated

Recall details

Recalling firm

Heartsine Technologies, Limited

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

Action taken

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.The company issued an additional press release on September 13, 2013 in a further attempt to reach out to end customers that had not yet responded to the companys efforts.

Root cause

Device Design

Status

Terminated

Product code

MKJ

Quantity affected

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,

Date initiated

2012-09-13

Date posted

2012-10-27

Date terminated

2015-07-10

Location

Belfast, United Kingdom

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