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U.S. Department of Health and Human Services

Class 2 Device Recall Heartstart

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  Class 2 Device Recall Heartstart see related information
Date Initiated by Firm November 02, 2009
Date Posted March 23, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = PHILIPS MEDICAL SYSTEMS
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