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U.S. Department of Health and Human Services

Class 2 Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family

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  Class 2 Device Recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family see related information
Date Initiated by Firm July 26, 2012
Date Posted January 04, 2013
Recall Status1 Terminated 3 on September 21, 2020
Recall Number Z-0643-2013
Recall Event ID 63030
510(K)Number K020715  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA.

The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
Code Information HS1 product family all start with A in the serial number and break down into 3 catalog numbers - M5066A, M5067A and M5068A:  1) M5066A (referred to as Onsite or HS1), Philips brand, 510 (k) = K020715, sold nationally and internationally, serial numbers range from A021-00038 through A12E-03490, with 306,108 total devices.  2) M5067A, Philips brand 510(k) = K040904, sold nationally and internationally, serial numbers range from A05C-00727 through A12D-01406, with 978 total devices.  3) M5068A, Philips brand 510(k) = K020715, sold nationally and internationally, serial numbers range from A021J-00207 through A12E-01900, with 22,760 total devices   4) M5066A, Laerdal brand, 510 (k) = K020715, sold internationally, serial numbers range from A021-00036 through A12D-02148, with 60,433 total devices.  5) M5067A, Laerdal brand, sold as Home device- cleared for OTC on initial 510(k) = K040904, serial numbers range from A021-00133 through A11B-00970, with 8659 total devices.  6) M5068A, Laerdal brand, 510(k) = K020715, sold internationally, serial numbers range from A02K-00172 through A11H-00868, with 5217 total devices.  Please note the serial number range represents first and last serial number for each model. Serial numbers are not continguous.  Laerdal is a distribution partner in EU and Canada, sold internationally 
Recalling Firm/
Manufacturer		 Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact AED Recall Support
800-263-3342 Ext. 6
Manufacturer Reason
for Recall		 Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6).
Quantity in Commerce Estimate 613,000 devices shipped
Distribution Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
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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