Recall Z-1107-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medica
| Date | Feb 26, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling |
| Root cause | Component design/selection |
| Action | Philips Healthcare issued a Customer Information Letter on January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers with an IFU Addendum titled: HeartStart XL+ Instructions for Use Addendum. Philips has revised the labeling in the addendum to specify the battery charge time with device turned off and AC power connected. The revised specification is: With temperature at 25C (77F), less than 3 hours to 100% capacity; less than 2 hours to 80% capacity. Please contact your local Philips Representative at 1- |
| Quantity | 7157 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL |
| 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 |