Class 2 Device Recall Heartstart

• Date Initiated by Firm: November 02, 2009
• Date Posted: March 23, 2010
• Recall Status: Terminated on May 23, 2013
• Recall Number: Z-1194-2010
• Recall Event ID: 53816
• 510(K)Number: K020715
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A
• Code Information: DOMESTIC UNIT SERIAL NUMBERS - A09J-01665, A09J-01237, A09J-02203, A09J-01279, A09J-01353, A09J-01284, A09J-01227, A09J-01593, A09J-01236, A09J-01238, A09J-01667, A09J-02140, A09J-02230, A09J-02238, A09J-01351, A09J-02218, A09J-01183, A09J-01232, A09J-01275, A09J-01277, A09J-01280, A09J-01283, A09J-01285, A09J-01286, A09J-01289, A09J-01290, A09J-01291, A09J-01654, A09J-01663, A09J-01669, A09J-01670, A09J-01727, A09J-02002, A09J-02139, A09J-02147, A09J-02148, A09J-02149, A09J-02202, A09J-02208, A09J-02211, A09J-02213, A09J-02219, A09J-02222, A09J-02224, A09J-02225, A09J-02226, A09J-02227, A09J-02228, A09J-02229, A09J-01354, A09J-01656, A09J-01664, A09J-02201, A09J-01229, A09J-01230, A09J-01287, A09J-01651, A09J-01652, A09J-01653, A09J-01657, A09J-01659, A09J-01660, A09J-01662, A09J-01666, A09J-01668, A09J-01225, A09J-01226, A09J-01231, A09J-01235, A09J-01329, A09J-01339, A09J-01356, A09J-01358, A09J-01655, A09J-01658, A09J-01661, A09J-01674, A09J-01675, A09J-01701, A09J-01708, A09J-01710, A09J-02102, A09J-02138, A09J-01153, A09J-01424, A09J-01426, A09J-01732, A09J-01733, A09J-01734, A09J-01736, A09J-02214, A09J-02221, A09J-02239, A09J-01292, A09J-01296, A09J-01297, A09J-01331, A09J-02235, and A09J-02237. 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• Recalling Firm/ Manufacturer: Philips Medical Systems; 2301 5th Ave Ste 200; Seattle WA 98121
• For Additional Information Contact: 206-664-5290
• Manufacturer Reason for Recall: Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 99 units to domestic consignees, 1178 units to international consignees
• Distribution: Worldwide Distribution.
• 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