Recall Z-1780-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
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.
| Date | Jul 9, 2008 (initiated Apr 30, 2008) |
| Status | Terminated |
| 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 so |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020715 | PHILIPS M5066A AND M5068A Philips Medical Systems, Nov 8, 2002 |