Events

Recall of HeartStart defibrillator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    47833
  • Event Risk Class
    Class 2
  • Event Number
    Z-1780-2008
  • Event Initiated Date
    2008-04-30
  • Event Date Posted
    2008-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70292
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Defibrillator - Product Code MKJ
  • Reason
    Buttons sticking - the on/off and shock buttons on the front panel of the device may stick in place when pressed and fail to respond to the button press, causing a delay in the delivery of a defibrillation shock when the system advises a shock.
  • Action
    Three separate Urgent - Device Recall letter were sent out on April 30, 2008 via tractable letter using UPS. 1) The end-customer letter advises of the recall, contact information to arrange a replacement of the device and instructions for checking the equipment to insure it is working correctly. "If your HeartStart Home Defibrillator is one of the affected devices or if you have any questions about this recall, please contact Philips Healthcare at 1.800.263.3342, option 5, or visit www.HeartStartHome.com to arrange for a free replacement defibrillator. If you have given your HeartStart to someone else as a gift, please call us promptly and let us know how to contact that person to arrange for the replacement. While waiting for your replacement unit, Philips recommends that you perform a battery insertion test (BLT) of your HeartStart, as described in the Owner's Manual provided with it. Simply remove the battery, wait 5 seconds, reinstall the battery, then press the shock button when directed. After the BIT has finished, press the green On/Off button twice. If either button does not seem to work, please contact Philips immediate." 2) The dealer/distributor and retail letters advises of the recall; request that the dealer/distributor provide end-customer information. "As part of a coordinated effort involving notification of regulatory authorities, other Philips entities, and support personnel, Philips will be contacting all affected customers directly. It is not necessary for you or your sub-distributors to contact customers." 3) The international customer contacts will be made via established Philips sales and distribution channels. Philips will be replacing international units under a Field Change Order Process (to be provided by the firm). In addition, Philips will provide a website that will provide customers with information related to the recall (www.HeartStartHome).

Device

HeartStart defibrillator
  • Model / Serial
    SN for Laedal "HeartStart Defibrillator": A05I-00051, A05I-00091, A05I-00103, A05I-00125, A05I-00178, A05I-00208, A05I-00211, A05I-00224, A05I-00263, A05I-00283, A05I-00285, A05I-00288, A05I-00289, A05I-00294, A05I-00295, A05I-00297, A05I-00298, A05I-00299, A05I-00300, A05I-00317, A05I-00324, A05I-00346, A05I-00351, A05I-00352, A05I-00353, A05I-00354, A05I-00355, A05I-00356, A05I-00357, A05I-00358, A05I-00359, A05I-00360, A05I-00361, A05I-00362, A05I-00363, A05I-00364, A05I-00365, A05I-00366, A05I-00367, A05I-00368, A05I-00369, A05I-00370, A05I-00371, A05I-00372, A05I-00373, A05I-00374, A05I-00375, A05I-00376, A05I-00377, A05I-00378, A05I-00379, A05I-00380, A05I-00381, A05I-00382, A05I-00383, A05I-00384, A05I-00385, A05I-00386, A05I-00387, A05I-00388, A05I-00389, A05I-00390, A05I-00391, A05I-00392, A05I-00393, A05I-00394, A05I-00395, A05I-00396, A05I-00397, A05I-00398, A05I-00399, A05I-00405, A05I-00451, A05I-00452, A05I-00454, A05I-00455, A05I-00456, A05I-00457, A05I-00458, A05I-00459, A05I-00460, A05I-00462, A05I-00467, A05I-00479, A05I-00488, A05I-00492, A05I-00502, A05I-00507, A05I-00508, A05I-00510, A05I-00519, A05I-00523, A05I-00524, A05I-00532, A05I-00561, A05I-00563, A05I-00598, A05I-00635, A05I-00639, A05I-00641, A05I-00642, A05I-00643, A05I-00647, A05I-00648, A05I-00650, A05I-00706, A05I-00709, A05I-00710, A05I-00711, A05I-00712, A05I-00714, A05I-00715, A05I-00718, A05I-00719, A05I-00720, A05I-00722, A05I-00723, A05I-00742, A05I-00743, A05I-00744, A05I-00746, A05I-00763, A05I-00766, A05I-00767, A05I-00769, A05I-00770, A05I-00774, A05I-00789, A05I-00790, A05I-00795, A05I-00797, A05I-00798, A05I-00809, A05I-00811, A05I-00827, A05I-00854, A05I-00855, A05I-00856, A05I-00860, A05I-00943, A05I-00944, A05I-00970, A05I-00989, A05I-00990, A05I-00991, A05I-01002, A05I-01007, A05I-01027, A05I-01028, A05I-01031, A05I-01036, A05I-01050, A05I-01065, A05I-01068, A05I-01071, A05I-01085, A05I-01095, A05I-01157, A05I-01158, A05I-01246, A05I-01283, A05I-01306, A05I-01346, A05I-01353, A05I-01403, A05I-01415, A05I-01422, A05I-01463, A05I-01497, A05I-01567, A05I-01573, A05I-01577, A05I-01583, A05I-01604, A05I-01625, A05I-01663, A05I-01679, A05I-01704, A05I-01725, A05I-01797, A05I-01838, A05I-01839, A05I-01840, A05I-01874, A05I-01889, A05I-01913, A05I-01981, A05I-01983, A05I-01984, A05I-02002, A05I-02072, A05I-02210, A05I-02324, A05I-02359, A05I-02463, A05I-02524, A05I-02652, A05I-02655, A05I-02672, A05I-02875, A05I-02937, A05I-03167, A05I-03260, A05I-03269, A05I-03421, A05I-03435, A05I-03500, A05I-03533, A05I-03538, A05I-03540, A05I-03627, A05I-03631, A05I-03863, A05I-03884, A05I-03917, A05I-03930, A05I-04017, A05I-04038, A05I-04061, A05I-04066, A05I-04073, A05I-04077, A05I-04078, A05I-04157, A05I-04160, A05I-04193, A05I-04198, A05I-04205, A05I-04248, A05I-04250, A05I-04254, A05I-04257, A05I-04262, A05I-04352, A05I-04469, A05I-04478, A05I-04554, A05I-04583, A05I-04599, A05I-04601, A05I-04615, A05I-04649, A05I-04676, A05I-04691, A05I-04694, A05I-04750, A05I-04751, A05I-04752
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and countries of Austria, Australia, Canada, Colombia, German, Denmark, Dominican Republic, Spain, France, England, Ireland, Italy, Japan, Netherlands, Norway, New Zealand, Panama, Sweden, Singapore, and South Africa.
  • Product Description
    Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA