FDA Medical Device Recalls (openFDA)
Philips Medical Systems: 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.
- Recall number
- Z-1780-2008
- Recalling firm
- Philips Medical Systems
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-04-30
- Posted
- 2008-07-09
- Terminated
- 2012-10-23
- 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.
- Root cause
- Component design/selection
- 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).
- Quantity
- 248 units
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K020715"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28