Recall Z-1225-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems North America Inc.
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victim
| Date | Mar 19, 2014 (initiated Feb 6, 2014) |
| Status | Terminated |
| Reason | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency. |
| Root cause | Process control |
| Action | Philips sent an Urgent Medical Device Recall Letter dated February 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week; a customer support representative will return your call promptly on the next business day. Customers who have an affected device |
| Quantity | 251 units total (128 in USA and 123 untils outside USA) |
| Distribution | Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of Australia, Austria, Canada, France, Germany, India, Italy, Ireland, Japan, Malaysia, Netherlands, Norway, Switzerland, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111693 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems, Oct 28, 2011 |