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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3270-2026

HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069

Publicado el 7 de octubre de 2026 · Inicio del retiro: 27 de julio de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
HeartSine Technologies Ltd
Distribuidor
U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Lote
Product - 350P US Device, US English - 2 Min CPR Item code: 350-STR-US-10 UDI-DI code: 0506016712067 Serial Numbers: 24D98056051D24 24D98057467D24 24D98057468D24 24D98057469D24 24D98068091E24 24D98068097E24 24D98070022F24 24D98070023F24 24D98070024F24 24D98070025F24 24D98070026F24 24D98070027F24 24D98070028F24 24D98070029F24 24D98070030F24 24D98070031F24 24D98070032F24 24D98070033F24 24D98070034F24 24D98070035F24 24D98070036F24 24D98070037F24 24D98070038F24 24D98070040F24 24D98070041F24 24D98070042F24 24D98070043F24 24D98070046F24 24D98070047F24 24D98070048F24 24D98070049F24 24D98070050F24 24D98070051F24 24D98070052F24 24D98070053F24 24D98070054F24 24D98070055F24 24D98070056F24 24D98070057F24 24D98070058F24 24D98070060F24 24D98070061F24 24D98070062F24 24D98070063F24 24D98070064F24 24D98070065F24 24D98070066F24 24D98070068F24 24D98070069F24 24D98070071F24 24D98070072F24 24D98070074F24 24D98070075F24 24D98070076F24 24D98070077F24 24D98070078F24 24D98070079F24 24D98070080F24 24D98070081F24 24D98070082F24 24D98070083F24 24D98070084F24 24D98070085F24 24D98070087F24 24D98070088F24 24D98070089F24 24D98070091F24 24D98070092F24 24D98070093F24 24D98070094F24 24D98070095F24 24D98070096F24 24D98070097F24 24D98070100F24 24D98070102F24 24D98070103F24 24D98070104F24 24D98070107F24 24D98070108F24 24D98070109F24 24D98070110F24 24D98070111F24 24D98070114F24 24D98070115F24 24D98070117F24 24D98070118F24 24D98070119F24 24D98070120F24 24D98070121F24 24D98070122F24 24D98070123F24 24D98070126F24 24D98070127F24 24D98070128F24 24D98070129F24 24D98070130F24 24D98070132F24 24D98070133F24 24D98070134F24 24D98070135F24 24D98070136F24 24D98070138F24 24D98070139F24 24D98070140F24 24D98070141F24 24D98070143F24 24D98070144F24 24D98070145F24 24D98070148F24 24D98070149F24 24D98070150F24 24D98070151F24 24D98070157F24 24D98070160F24 24D98070161F24 24D98070162F24 24D98070163F24 24D98070166F24 24D98056785D24 24D98057279D24 24D98057648D24 24D98053900E24 24D98054669E24 24D98054543E24 24D98054034E24 24D98050678E24 24D98050536E24 24D98055040E24 24D98055328E24 24D98050945E24 24D98055733E24 24D98070147F24 24D98070039F24 24D98070101F24 24D98070105F24 24D98070146F24 24D98070045F24 24D98070067F24 24D98070116F24 24D98070099F24 24D98070044F24 24D98070098F24 24D98070059F24 24D98070073F24 24D98070090F24 24D98070142F24 24D98070124F24 24D98070113F24 24D98070131F24 24D98070112F24 24D98070125F24 24D98070412F24 24D98026634F24 24D98026619F24 24D98048208F24 24D98026934F24 24D98026936F24 24D98048576F24 24D98048559F24 24D98048502F24 24D98048594F24 24D98048571F24 24D98048600F24 24D98048566F24 24D98048609F24 24D98048588F24 24D98048578F24 24D98048554F24 24D98048499F24 24D98048503F24 24D98048504F24 24D98048574F24 24D98048582F24 24D98048491F24 24D98048556F24 24D98048597F24 24D98048598F24 24D98048570F24 24D98048712F24 24D98048560F24 24D98048500F24 24D98048595F24 24D98048575F24 24D98048709F24 24D98048603F24 24D98048495F24 24D98048617F24 24D98048492F24 24D98048497F24 24D98048558F24 24D98048605F24 24D98048710F24 24D98048565F24 24D98048586F24 24D98048604F24 24D98048561F24 24D98048606F24 24D98048589F24 24D98048555F24 24D98048564F24 24D98048614F24 24D98048599F24 24D98048590F24 24D98048591F24 24D98048583F24 24D98048601F24 24D98048580F24 24D98048573F24 24D98048618F24 24D98048577F24 24D98048567F24 24D98048501F24 24D98048610F24 24D98048607F24 24D98048711F24 24D98048557F24 24D98048616F24 24D98048585F24 24D98048572F24 24D98048608F24 24D98048592F24 24D98048593F24 24D98048569F24 24D98048619F24 24D98048579F24 24D98048602F24 24D98048498F24 24D98048496F24 24D98048581F24 24D98048587F24 24D98048562F24 24D98048596F24 24D98048611F24 24D98048568F24 24D98048615F24 24D98048584F24 24D98048563F24 24D98026922F24 24D98026921F24 24D98048625F24 24D98026935F24 24D98026838F24 24D98026836F24 24D98026834F24 24D98026928F24 24D98026868F24 24D98026869F24 24D98026933F24 24D98048388F24 24D98028430G24 24D98062685G24 24D98071182G24 24D98071082G24 24D98038091G24 24D98071057G24 24D98038146G24 24D98038133G24 24D98074601G24 24D98074572G2
Clasificación de riesgo
Class III
Área (FDA)
device
País
United Kingdom

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Preguntas sobre este retiro

¿HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 fue retirado del mercado?

Sí. FDA publicó el retiro Z-3270-2026 el 7 de octubre de 2026. Peligro reportado: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

¿Qué debo hacer si tengo este producto?

Voluntary: Firm initiated · Letter

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