| Class 2 Device Recall Heartstart | |
Date Initiated by Firm | November 02, 2009 |
Date Posted | March 23, 2010 |
Recall Status1 |
Terminated 3 on May 23, 2013 |
Recall Number | Z-1196-2010 |
Recall Event ID |
53816 |
510(K)Number | K040904 |
Product Classification |
Over-The-Counter Automated External Defibrillator - Product Code NSA
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Product | Heartstart HS1 Defibrillator Model M5068A |
Code Information |
DOMESTIC UNIT SERIAL NUMBERS - A09J-02644, A09J-02180, A09J-02643, A09J-02499, A09J-02169, A09J-02175, A09J-02554, A09J-02645, A09J-01891, A09J-02382, A09J-01903, A09J-02361, A09J-02380, A09J-02033, A09J-02409, A09J-01904, A09J-02351, A09J-02384, A09J-02675, A09J-02625, A09J-02628, A09J-01901, A09J-02360, A09J-02485, A09J-02631, A09J-02642, A09J-02641, A09J-02383, A09J-02647, A09J-02693, A09J-02269, and A09J-02552., A09J-02493, and A09J-01974. |
Recalling Firm/ Manufacturer |
Philips Medical Systems 2301 5th Ave Ste 200 Seattle WA 98121
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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 | 34 units distributed domestically |
Distribution | Worldwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NSA
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