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HeartSine Technologies Ltd Recall 94076

Description: HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

HeartSine Technologies Ltd Recall 94076 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1820-2024
Event ID94076
Event DescriptionHeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Product TypeDevices
DistributionUS Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
Recall ReasonAutomated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Device Classification20240522
Device Code InfoUDI-DI: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 5060167122514, 5060167121371, 5060167120671, 5060167121630, 5060167128042, 5060167120701, 5060167128080, 5060167120695, 5060167120725, 5060167120718, 5060167120909, 5060167120916, 5060167122071, 5060167120893. Devices affected by this notification begin with the following prefixes and device codes: 16D, 16E, 16G, 17D, 17E, 17G, 18D, 18E, 18G, 19D, 19E, 19G, 20D, 20E, 20G, 21D, 21E, 21G, 22D, 22E, 22G, 23D, 23E, 23G, 24D, 24E, 24G Serial Numbers: The prefix (device identifier) consists of the manufacturing date (YY) and the device model (B, D, E, G, or H) and an 8-digit serial number string. Example: 16D00001234
Center Classification Date20240514
Recall Initiation Date20240408
Recalling FirmHeartSine Technologies Ltd
Initial Notification Letter
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