Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
Publicado el 26 de marzo de 2014 · Inicio del retiro: 6 de febrero de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems North America Inc.
- Distribuidor
- Worldwide Distribution - USA Nationwide
- Lote
- SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, A13G-00081, A13G-00082, A13G-00083, A13G-00084, A13G-00085, A13G-00086, A13G-00087, A13G-00088, A13G-00089, A13G-00090, A13G-00091, A13G-00092, A13G-00093, A13G-00095, A13G-00096, A13G-00097, A13G-00098, A13G-00099, A13G-00100, A13G-00101, A13G-00102, A13G-00103, A13G-00104, A13G-00105, A13G-00106, A13G-00107, A13G-00108, A13G-00109, A13G-00110, A13G-00111, A13G-00112, A13G-00114, A13G-00115, A13G-00116, A13G-00117, A13G-00118, A13G-00119, A13G-00120, A13G-00122, A13G-00123, A13G-00124, A13G-00125, A13G-00126, A13G-00127, A13G-00128, A13G-00129, A13G-00130, A13G-00131, A13G-00132, A13G-00133, A13G-00134, A13G-00135, A13G-00136, A13G-00137, A13G-00138, A13G-00139, A13G-00140, A13G-00141, A13G-00142, A13G-00143, A13G-00144, A13G-00145, A13G-00146, A13G-00147, A13G-00148, A13G-00149, A13G-00150, A13G-00151, A13G-00152, A13G-00153, A13G-00154, A13G-00155, A13G-00156, A13G-00157, A13G-00158, A13G-00159, A13G-00160, A13G-00161, A13G-00162, A13G-00163, A13G-00164, A13G-00165, A13G-00166, A13G-00167, A13G-00168, A13G-00169, A13G-00170, A13G-00171, A13G-00172, A13G-00173, A13G-00174, A13G-00175, A13G-00176, A13G-00177, A13G-00178, A13G-00179, A13G-00180, A13G-00181, A13G-00182, A13G-00183, A13G-00184, A13G-00185, A13G-00186, A13G-00187, A13G-00188, A13G-00189, A13G-00190, A13G-00192, A13G-00193, A13G-00194, A13G-00195, A13G-00196, A13G-00197, A13G-00198, A13G-00199, A13G-00201, A13G-00202, A13G-00204, A13G-00215, A13G-00222, A13G-00223, A13G-00258, A13G-00259, A13G-00260, A13G-00261, A13G-00262, A13G-00263, A13G-00264, A13G-00265, A13G-00277, A13G-00288, A13G-00289, A13G-00294, A13G-00325, A13G-00336, A13G-00337, A13G-00338, A13G-00339, A13G-00340, A13G-00341, A13G-00342, A13G-00343, A13G-00344, A13G-00345, A13G-00355, A13G-00356, A13G-00359, A13G-00375, A13G-00376, A13G-00377, A13G-00378, A13G-00379, A13G-00380, A13G-00381, A13G-00403, A13G-00404, A13G-00406, A13G-00407, A13G-00408, A13G-00409, A13G-00410, A13G-00415, A13G-00417, A13G-00418, A13G-00419, A13G-00420, A13G-00421, A13G-00423, A13G-00435, A13G-00444, A13G-00448, A13G-00449, A13G-00450, A13G-00451, A13G-00452, A13G-00453, A13G-00454, A13G-00455, A13G-00456, A13G-00457, A13G-00458, A13G-00459, A13G-00460, A13G-00461, A13G-00462, A13G-00463, A13G-00464, A13G-00465, A13G-00466, A13G-00468, A13G-00469, A13G-00470, A13G-00477, A13G-00478, A13G-00485, A13G-00490, A13G-00493, A13G-00495, A13G-00496, A13G-00497, A13G-00498, A13G-00499, A13G-00500, A13G-00501, A13G-00502, A13G-00503, A13G-00509, A13G-00511, A13G-00513, A13G-00514, A13G-00552, A13G-00554, A13G-00555, A13G-00559, A13G-00561, A13G-00562, A13G-00563, A13G-00565, A13G-00569, A13G-00572, A13G-00573, A13G-00577, A13G-00588, A13G-00610, A13G-00611, A13G-00612, A13G-00614, A13G-00615, A13G-00620, A13G-00621, A13G-00622, A13G-00623, A13G-00624, A13G-00626, A13G-00627, A13G-00633, A13G-00635, A13G-00637, A13G-00639, A13G-00643, A13G-00653, A13G-00659, A13G-00660, A13G-00661, A13G-00662, A13G-00663, A13G-00664, A13G-00674, A13G-00676, A13G-00677, A
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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