HeartSine Technologies Ltd: HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)

Hazard

Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)

Details from the source

Reason for recall: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Indonesia, Ireland, Isra Quantity: 190,516 units Lot/code info: U.S. Model 350P Item Number: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers 23D98002591E23 23D98002593E23 23D98002594E23 23D98002595E23 23D98002597E23 23D98002608E23 23D98002638E23 23D98002668E23 23D98002669E23 23D98002699E23 23D98002734E23 23D98002751E23 23D98002755E23 23D98002756E23 23D98002758E23 23D98002760E23 23D98002761E23 23D98002765E23 23D98002772E23 23D98002773E23 23D98002774E23 23D98002845E23 23D98002852E23 23D98002853E23 23D98002855E23 23D98002856E23 23D98002857E23 23D98002858E23 23D98002859E23 23D98002877E23 23D98002879E23 23D98002885E23 23D98002887E23 23D98002987E23 23D98002989E23 23D98002990E23 23D98003083E23 23D98003092E23 23D98003117I23 23D98003118E23 23D98003459D23 23D98003475D23 23D98008368E23 23D98008390E23 23D98008877E23 23D98011224D23 23D98012987E23 23D98012991E23 23D98012993E23 23D98012994E23 23D98012998E23 23D98012999E23 23D98013490F23 23D98013500F23 23D98016785E23 23D98017244E23 23D98020031C23 23D98020033C23 23D98020036C23 23D98020351C23 23D98020356C23 23D98020386C23 23D98020403C23 23D98020405C23 23D98020406C23 23D98020408C23 23D98020420C23 23D98020592D23 23D98020594D23 23D98020622D23 23D98020623D23 23D98020627D23 23D98020628D23 23D98020629D23 23D98020631D23 23D98020639D23 23D98020640D23 23D98020732D23 23D98023168E23 23D98100628I23 23D98100631I23 23D98100634I23 23D98100648I23 23D98102318K23 23D98104318J23 23D98104432J23 23D98104622J23 23D98104623J23 23D98104624J23 23D98104628J23 23D98104700J23 23D98104737J23 23D98104741J23 23D98104835J23 23D98

UPC codes

0506016712067, 0506016712068, 0506016712069, 0506016712070, 05060167128042, 0506016712806, 0506016712808, 0506016712235, 0506016712473, 0506016712137, 0506016712970, 0506016712138, 0506016712474, 0506016712159

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.