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-1195-2010
• Recall Event ID: 53816
• 510(K)Number: K020715
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A
• Code Information: Serial number A09J-02205
• 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: 1 unit internationally
• 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