Class 2 Device Recall Philips Heartstart FRx

• Date Initiated by Firm: April 30, 2010
• Date Posted: June 28, 2010
• Recall Status: Terminated on December 10, 2012
• Recall Number: Z-1915-2010
• Recall Event ID: 55579
• 510(K)Number: K050004
• Product Classification: Automated External Defibrillator - Product Code MKJ
• Product: Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model number 861304). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
• Code Information: DeviceSN: B10C-02133, B10C-02135, B10C-02136, B10C-02172, B10C-02196, B10C-02475, B10C-02477, B10C-02478, B10C-02480, B10C-02481, B10C-02494, B10C-02495, B10C-02499, B10C-02610, B10C-02631, B10C-02634, B10C-02639, B10C-02640, B10C-02641, B10C-02644, B10C-02645, B10C-02646, B10C-02647, B10C-02648, B10C-02651, B10C-02652, B10C-02653, B10C-02654, B10C-02655, B10C-02660, B10C-02674, B10C-02685, B10C-02702, B10C-02704, B10C-02705, B10C-02706, B10C-02707, B10C-02708, B10C-02709, B10C-02712, B10C-02713, B10C-02715, B10C-02717, B10C-02718, B10C-02719, B10C-02720, B10C-02721, B10C-02722, B10C-02723, B10C-02724, B10C-02725, B10C-02729, B10C-02732, B10C-02733, B10C-02734, B10C-02735, B10C-02736, B10C-02740, B10C-02742, B10C-02743, B10C-02744, B10C-02745, B10C-02746, B10C-02747, B10C-02749, B10C-02771, B10C-02779, B10C-02780, B10C-02781, B10C-02782, B10C-02783, B10C-02784, B10C-02785, B10C-02801, B10C-02805, B10C-02806, B10C-02816, B10C-02818, B10C-02822, B10C-02823, B10C-02824, B10C-02826, B10C-02830, B10C-02831, B10C-02832, B10C-02835, B10C-02836, B10C-02837, B10C-02838, B10C-02839, B10C-02840, B10C-02841, B10C-02843, B10C-02844, B10C-02845, B10C-02846, B10C-02847, B10C-02848, B10C-02849, B10C-02850, B10C-02851, B10C-02852, B10C-02853, B10C-02854, B10C-02855, B10C-02856, B10C-02858, B10C-02879, B10C-02881, B10C-02884, B10C-02886, B10C-02895, B10C-02896, B10C-02897, B10C-02900, B10C-02904, B10C-02905, B10C-02906, B10C-02907, B10C-02908, B10C-02909, B10C-02910, B10C-02911, B10C-02912, B10C-02913, B10C-02914, B10C-02915, B10C-02917, B10C-02919, B10C-02928, B10C-02929, B10C-02933, B10C-02937, B10C-02938, B10C-02943, B10C-02947, B10C-02948, B10C-02949, B10C-02950, B10C-02957, B10C-02965, B10C-03018, B10C-03019, B10C-03020, B10C-03021, B10C-03023, B10C-03024, B10C-03026, B10C-03040, B10C-03041, B10C-03042, B10C-03043, B10C-03045, B10C-03046, B10C-03047, B10C-03048, B10C-03049, B10C-03050, B10C-03119, B10C-03120, B10C-03121, B10C-03122, B10C-03123, B10C-03124, B10C-03125, B10C-03126, B10C-03127, B10C-03128, B10C-03156, B10C-03157, B10C-03158, B10C-03159, B10C-03160, B10C-03171, B10C-03175, B10C-03176, B10C-03178, B10C-03179, B10C-03180, B10C-03182, B10C-03194, B10C-03195, B10C-03196, B10C-03197, B10C-03198, B10C-03199, B10C-03200, B10C-03202, B10C-03203, B10C-03204, B10C-03205, B10C-03207, B10C-03208, B10C-03212, B10C-03213, B10C-03218, B10C-03247, B10C-03248, B10C-03251, B10C-03253, B10C-03255, B10C-03256, B10C-03257, B10C-03258, B10C-03259, B10C-03260, B10C-03262, B10C-03263, B10C-03265, B10C-03266, B10C-03267, B10C-03268, B10C-03269, B10C-03270, B10C-03271, B10C-03272, B10C-03273, B10C-03274, B10C-03275, B10C-03276, B10C-03286, B10C-03287, B10C-03288, B10C-03289, B10C-03290, B10C-03291, B10C-03292, B10C-03293, B10C-03295, B10C-03296, B10C-03297, B10C-03310, B10C-03329, B10C-03330, B10C-03332, B10C-03334, B10C-03335, B10C-03336, B10C-03338, B10C-03339, B10C-03340, B10C-03342, B10C-03349, B10C-03350, B10C-03355, B10C-03359, B10C-03360, B10C-03361, B10C-03362, B10C-03363, B10C-03364, B10C-03366, B10C-03367, B10C-03369, B10C-03384, B10C-03386, B10C-03437, B10C-03450, B10C-03451, B10C-03452, B10C-03453, B10C-03483, B10C-03484, B10C-03486, and B10C-03901.
• Recalling Firm/ Manufacturer: Philips Medical Systems; 2301 5th Ave Ste 200; Seattle WA 98121
• For Additional Information Contact: Dan Donnelly; 206-664-5290
• Manufacturer Reason for Recall: Seventeen AEDs failed production line testing (Final Acceptance Test).
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.
• Quantity in Commerce: 265
• Distribution: Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
• 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