Recall Z-2328-2015 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: 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 medic
| Date | Aug 4, 2015 (initiated Jun 5, 2015) |
| Status | Terminated |
| Reason | Multiple software and hardware issues with device that can affect its function. |
| Root cause | Device Design |
| Action | On June 29, 2015, Philips sent an Urgent Medical Device Correction notification/Field Safety Notice (FSN) to inform customers of the issue. The FSN identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. An upgrade consisting of both software and hardware will be provided free of charge for all units affected by these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Philips is asking customers to |
| Quantity | 13,168 devices |
| Distribution | Worldwide Distribution - US Nationwide including PUERTO RICO, Canada, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICA, DOMINICAN |
| 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 |