—#86576

Product

Philips Heartstart FRx automated external defibrillator (AED), Model 861304

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K050004
Affected lot / code info: DOMESTIC UNIT SERIAL NUMBERS - B09J-00860, B09J-00792, B09J-00810, B09J-00877, B09J-00878, B09J-00793, B09J-01110, B09J-00849, B09J-01016, B09J-01196, B09J-01299, B09J-00855, B09J-00805, B09J-01193, B09J-00896, B09J-00824, B09J-00821, B09J-00823, B09J-00825, B09J-00835, B09J-02749, B09J-00794, B09J-00856, B09J-00889, B09J-00891, B09J-00897, B09J-01005, B09J-01012, B09J-01197, B09J-01230, B09J-01269, B09J-01279, B09J-00791, B09J-00818, B09J-00875, B09J-01082, B09J-01100, B09J-01260, B09J-01010, B09J-01018, B09J-01021, B09J-01022, B09J-01108, B09J-01114, B09J-01120, B09J-01080, B09J-01014, B09J-01298, B09J-01300, B09J-01257, B09J-00872, B09J-00803, B09J-00804, B09J-00868, B09J-01013, B09J-01019, B09J-01020, B09J-01123, B09J-01258, B09J-00786, B09J-00817, B09J-00790, B09J-00816, B09J-01122, B09J-01162, B09J-00789, B09J-00795, B09J-00798, B09J-00806, B09J-00807, B09J-00808, B09J-00842, B09J-00847, B09J-00879, B09J-00892, B09J-01002, B09J-01003, B09J-01006, B09J-01007, B09J-00813, B09J-00819, B09J-00820, B09J-00853, B09J-00884, B09J-01015, B09J-01139, B09J-01252, B09J-01259, B09J-00787, B09J-01253, B09J-01303, and B09J-00898. I INTERNATIONAL UNIT SERIAL NUMBERS - B09J-02902, B09J-02630, B09J-02914, B09J-02920, B09J-02921, B09J-01243, B09J-02588, B09J-02802, B09J-02911, B09J-02929, B09J-02918, B09J-02398, B09J-02744, B09J-02922, B09J-02935, B09J-01078, B09J-01341, B09J-01348, B09J-01349, B09J-01350, B09J-01364, B09J-01365, B09J-01369, B09J-01373, B09J-01375, B09J-01388, B09J-01390, B09J-01391, B09J-01392, B09J-01393, B09J-01395, B09J-01396, B09J-01397, B09J-01398, B09J-01399, B09J-01401, B09J-01402, B09J-01403, B09J-01407, B09J-01409, B09J-01411, B09J-01414, B09J-01424, B09J-01425, B09J-01428, B09J-01440, B09J-01443, B09J-01460, B09J-01461, B09J-01462, B09J-01463, B09J-01501, B09J-01515, B09J-01516, B09J-01520, B09J-01523, B09J-01524, B09J-01530, B09J-01531, B09J-01532, B09J-01533, B09J-01534, B09J-01535, B09J-01544, B09J-01545, B09J-01546, B09J-01547, B09J-01548, B09J-01549, B09J-01601, B09J-01602, B09J-01603, B09J-01604, B09J-01605, B09J-01606, B09J-01607, B09J-01630, B09J-01636, B09J-01637, B09J-01639, B09J-01640, B09J-01641, B09J-01642, B09J-01646, B09J-01647, B09J-01648, B09J-01651, B09J-01659, B09J-01660, B09J-01662, B09J-01664, B09J-01667, B09J-01668, B09J-01677, B09J-01678, B09J-01680, B09J-01681, B09J-01682, B09J-01683, B09J-01685, B09J-01687, B09J-01688, B09J-01689, B09J-01690, B09J-01691, B09J-01695, B09J-01696, B09J-01699, B09J-01700, B09J-01701, B09J-01702, B09J-01703, B09J-01704, B09J-01705, B09J-01706, B09J-01709, B09J-01712, B09J-01715, B09J-01716, B09J-01717, B09J-01718, B09J-01719, B09J-01720, B09J-01721, B09J-01722, B09J-01723, B09J-01724, B09J-01725, B09J-01726, B09J-01727, B09J-01728, B09J-01729, B09J-01730, B09J-01731, B09J-01733, B09J-01734, B09J-01735, B09J-01737, B09J-01738, B09J-01739, B09J-01740, B09J-01741, B09J-01742, B09J-01743, B09J-01744, B09J-01745, B09J-01746, B09J-01747, B09J-01748, B09J-01749, B09J-01750, B09J-01751, B09J-01752, B09J-01753, B09J-01754, B09J-01755, B09J-01756, B09J-01757, B09J-01758, B09J-01759, B09J-01760, B09J-01761, B09J-01762, B09J-01765, B09J-01766, B09J-01768, B09J-01769, B09J-01770, B09J-01771, B09J-01772, B09J-01773, B09J-01775, B09J-01776, B09J-01777, B09J-01778, B09J-01779, B09J-01780, B09J-01781, B09J-01782, B09J-01784, B09J-01785, B09J-01786, B09J-01787, B09J-01788, B09J-01789, B09J-01792, B09J-01793, B09J-01794, B09J-01795, B09J-01796, B09J-01797, B09J-01798, B09J-01800, B09J-01802, B09J-01803, B09J-01804, B09J-01807, B09J-01809, B09J-01828, B09J-01831, B09J-01832, B09J-01834, B09J-01836, B09J-01837, B09J-01838, B09J-01841, B09J-01842, B09J-01843, B09J-01844, B09J-01845, B09J-01856, B09J-01870, B09J-01871, B09J-01872, B09J-01873, B09J-01874, B09J-01875, B09J-01876, B09J-01877, B09J-01878, B09J-01879, B09J-01880, B09J-01882, B09J-01883, B09J-01884, B09J-01885, B09J-01888, B09J-01891, B09J-01893, B09J-01894, B09J-01897, B09J-01898, B09J-01899, B09J-01901, B09J-01902, B09J-01903, B09J-01904, B09J-01905, B09J-01906, B09J-01907, B09J-01908, B09J-01909, B09J-01910, B09J-01911, B09J-01912, B09J-01913, B09J-01914, B09J-01915, B09J-01917, B09J-01918, B09J-01920, B09J-01928, B09J-01930, B09J-01932, B09J-01942, B09J-01944, B09J-01946, B09J-01948, B09J-01949, B09J-01950, B09J-01951, B09J-01953, B09J-01954, B09J-01955, B09J-01956, B09J-01957, B09J-01958, B09J-01959, B09J-01962, B09J-01963, B09J-01964, B09J-01970, B09J-01971, B09J-01972, B09J-01976, B09J-01980, B09J-01982, B09J-01987, B09J-01988, B09J-01992, B09J-01994, B09J-01995, B09J-01997, B09J-02001, B09J-02003, B09J-02004, B09J-02005, B09J-02006, B09J-02007, B09J-02008, B09J-02009, B09J-02011, B09J-02012, B09J-02018, B09J-02020, B09J-02021, B09J-02023, B09J-02029, B09J-02031, B09J-02046, B09J-02047, B09J-02050, B09J-02051, B09J-02057, B09J-02060, B09J-02061, B09J-02063, B09J-02064, B09J-02065, B09J-02066, B09J-02067, B09J-02069, B09J-02092, B09J-02101, B09J-02103, B09J-02106, B09J-02109, B09J-02121, B09J-02122, B09J-02132, B09J-02133, B09J-02134, B09J-02135, B09J-02137, B09J-02143, B09J-02146, B09J-02148, B09J-02149, B09J-02154, B09J-02156, B09J-02161, B09J-02162, B09J-02168, B09J-02171, B09J-02179, B09J-02261, B09J-02263, B09J-02265, B09J-02269, B09J-02272, B09J-02273, B09J-02276, B09J-02278, B09J-02280, B09J-02281, B09J-02320, B09J-02328, B09J-02333, B09J-02416, B09J-02426, B09J-02429, B09J-02519, B09J-02527, B09J-02528, B09J-02530, B09J-02531, B09J-02532, B09J-02535, B09J-02539, B09J-02543, B09J-02545, B09J-02546, B09J-02547, B09J-02553, B09J-02559, B09J-02830, B09J-02831, B09J-02949, B09J-01335, B09J-01339, B09J-01344, B09J-01346, B09J-01502, B09J-01504, B09J-01505, B09J-01509, B09J-01511, B09J-01517, B09J-01521, B09J-01525, B09J-01526, B09J-01528, B09J-01672, B09J-01673, B09J-01694, B09J-01698, B09J-01096, B09J-01191, B09J-01231, B09J-01232, B09J-01236, B09J-01237, B09J-01238, B09J-01242, B09J-01249, B09J-01250, B09J-01306, B09J-01307, B09J-01308, B09J-01309, B09J-01311, B09J-01312, B09J-01314, B09J-01316, B09J-02386, B09J-02396, B09J-02448, B09J-02746, B09J-02803, B09J-02906, B09J-02917, B09J-02923, B09J-02932, B09J-01248, B09J-01305, B09J-01310, B09J-01313, B09J-01315, B09J-01320, B09J-01321, B09J-01322, B09J-01324, B09J-01325, B09J-01326, B09J-01328, B09J-01329, B09J-01330, B09J-01333, B09J-01336, B09J-01337, B09J-01340, B09J-01342, B09J-01343, B09J-01097, B09J-01240, B09J-01241, B09J-01245, B09J-01079, B09J-01332, B09J-01334, B09J-01338, B09J-01347, B09J-01503, B09J-01508, B09J-01510, B09J-01514, B09J-01522, B09J-01666, B09J-01671, B09J-02497, B09J-02631, and B09J-02647.

Why it was recalled

Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.

Recalling firm

Firm: Philips Medical Systems
Address: 2301 5th Ave, Ste 200, Seattle, Washington 98121

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2009-11-02
Posted by FDA: 2010-03-23
Terminated: 2013-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.