International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

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Type of Event
Recall
Event ID
53816
Event Risk Class
Class 2
Event Number
Z-1193-2010
Event Initiated Date
2009-11-02
Event Date Posted
2010-03-23
Event Status
Terminated
Event Country
United States
Event Terminated Date
2013-05-23
Event Source
USFDA
Event Source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86576
Notes / Alerts

U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data

Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Reason
Potential for failure of a capacitor during use which would prevent the aed from delivering effective defibrillation therapy when indicated.
Action
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.

Device

Device Recall Heartstart

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution.
Product Description
Philips Heartstart FRx automated external defibrillator (AED), Model 861304
Manufacturer
Philips Medical Systems

Manufacturer

Philips Medical Systems

Manufacturer Address
Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Recall of Device Recall Heartstart

What is this?

Device

Device Recall Heartstart

Manufacturer

Philips Medical Systems