FDAFDA · Food and drugs·Recall number Z-1232-2014

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).

Published March 26, 2014 · Recall initiated: February 6, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Philips Medical Systems North America Inc.
Distributor: Worldwide Distribution - USA Nationwide
Lot: 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
Risk classification: Class II
Area (FDA): device
Country: United States

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