Recall Z-2053-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician.
| Date | Apr 13, 2020 |
| Status | Terminated |
| Reason | The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed. |
| Root cause | Process control |
| Action | On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior: - The device may not turn on. - The device may not perform the selected function. - The device may deliver a shock with an energy level different from the setting selected by the user. There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch. Customers were advised that the HeartStart XL Defi |
| Quantity | 94,034 units |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A Agilent Technologies, Inc., Sep 8, 2000 |