Recall Z-1439-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
| Date | Apr 9, 2014 (initiated Mar 31, 2014) |
| Status | Terminated |
| Reason | A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy |
| Root cause | Reprocessing Controls |
| Action | Philips Healthcare issued an Urgent-Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to |
| Quantity | 19 units |
| Distribution | Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES Philips Medical Systems, Feb 16, 2012 |