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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

Product Description 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.
Recall Number Z-0643-2013
Classification Class II
Code Info 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
Product Distributed Qty Estimate 613,000 devices shipped
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 of all owners contacting their local Philips representative if an affected FRx or HS1 AED has emitted a pattern of triple chirps. If the device is emitting a pattern of triple chirps, it is a signal that the defibrillator's behavior needs to be investigated by Philips.

Event Detail

Event Id 63030
Product Type Devices
Status Ongoing
Recalling Firm Philips Medical Systems North America Co. Phillips
City Bothell
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.