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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart defibrillator

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  Class 2 Device Recall HeartStart defibrillator see related information
Date Initiated by Firm April 30, 2008
Date Posted July 09, 2008
Recall Status1 Terminated 3 on October 23, 2012
Recall Number Z-1780-2008
Recall Event ID 47833
510(K)Number K020715  
Product Classification Defibrillator - Product Code MKJ
Product Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
Code Information SN for Laedal "HeartStart Defibrillator": A05I-00051, A05I-00091, A05I-00103, A05I-00125, A05I-00178, A05I-00208, A05I-00211, A05I-00224, A05I-00263, A05I-00283, A05I-00285, A05I-00288, A05I-00289, A05I-00294, A05I-00295, A05I-00297, A05I-00298, A05I-00299, A05I-00300, A05I-00317, A05I-00324, A05I-00346, A05I-00351, A05I-00352, A05I-00353, A05I-00354, A05I-00355, A05I-00356, A05I-00357, A05I-00358, A05I-00359, A05I-00360, A05I-00361, A05I-00362, A05I-00363, A05I-00364, A05I-00365, A05I-00366, A05I-00367, A05I-00368, A05I-00369, A05I-00370, A05I-00371, A05I-00372, A05I-00373, A05I-00374, A05I-00375, A05I-00376, A05I-00377, A05I-00378, A05I-00379, A05I-00380, A05I-00381, A05I-00382, A05I-00383, A05I-00384, A05I-00385, A05I-00386, A05I-00387, A05I-00388, A05I-00389, A05I-00390, A05I-00391, A05I-00392, A05I-00393, A05I-00394, A05I-00395, A05I-00396, A05I-00397, A05I-00398, A05I-00399, A05I-00405, A05I-00451, A05I-00452, A05I-00454, A05I-00455, A05I-00456, A05I-00457, A05I-00458, A05I-00459, A05I-00460, A05I-00462, A05I-00467, A05I-00479, A05I-00488, A05I-00492, A05I-00502, A05I-00507, A05I-00508, A05I-00510, A05I-00519, A05I-00523, A05I-00524, A05I-00532, A05I-00561, A05I-00563, A05I-00598, A05I-00635, A05I-00639, A05I-00641, A05I-00642, A05I-00643, A05I-00647, A05I-00648, A05I-00650, A05I-00706, A05I-00709, A05I-00710, A05I-00711, A05I-00712, A05I-00714, A05I-00715, A05I-00718, A05I-00719, A05I-00720, A05I-00722, A05I-00723, A05I-00742, A05I-00743, A05I-00744, A05I-00746, A05I-00763, A05I-00766, A05I-00767, A05I-00769, A05I-00770, A05I-00774, A05I-00789, A05I-00790, A05I-00795, A05I-00797, A05I-00798, A05I-00809, A05I-00811, A05I-00827, A05I-00854, A05I-00855, A05I-00856, A05I-00860, A05I-00943, A05I-00944, A05I-00970, A05I-00989, A05I-00990, A05I-00991, A05I-01002, A05I-01007, A05I-01027, A05I-01028, A05I-01031, A05I-01036, A05I-01050, A05I-01065, A05I-01068, A05I-01071, A05I-01085, A05I-01095, A05I-01157, A05I-01158, A05I-01246, A05I-01283, A05I-01306, A05I-01346, A05I-01353, A05I-01403, A05I-01415, A05I-01422, A05I-01463, A05I-01497, A05I-01567, A05I-01573, A05I-01577, A05I-01583, A05I-01604, A05I-01625, A05I-01663, A05I-01679, A05I-01704, A05I-01725, A05I-01797, A05I-01838, A05I-01839, A05I-01840, A05I-01874, A05I-01889, A05I-01913, A05I-01981, A05I-01983, A05I-01984, A05I-02002, A05I-02072, A05I-02210, A05I-02324, A05I-02359, A05I-02463, A05I-02524, A05I-02652, A05I-02655, A05I-02672, A05I-02875, A05I-02937, A05I-03167, A05I-03260, A05I-03269, A05I-03421, A05I-03435, A05I-03500, A05I-03533, A05I-03538, A05I-03540, A05I-03627, A05I-03631, A05I-03863, A05I-03884, A05I-03917, A05I-03930, A05I-04017, A05I-04038, A05I-04061, A05I-04066, A05I-04073, A05I-04077, A05I-04078, A05I-04157, A05I-04160, A05I-04193, A05I-04198, A05I-04205, A05I-04248, A05I-04250, A05I-04254, A05I-04257, A05I-04262, A05I-04352, A05I-04469, A05I-04478, A05I-04554, A05I-04583, A05I-04599, A05I-04601, A05I-04615, A05I-04649, A05I-04676, A05I-04691, A05I-04694, A05I-04750, A05I-04751, A05I-04752
Recalling Firm/
Manufacturer		 Philips Medical Systems
2301 5th Ave Ste 200
Seattle WA 98121
For Additional Information Contact Dennis Daniels
206-664-5000
Manufacturer Reason
for Recall		 Buttons Sticking - The On/Off and Shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
FDA Determined
Cause 2		 Component design/selection
Action Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).
Quantity in Commerce 248 units
Distribution Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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