Z-2794-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 16, 2020
- Termination Date
- August 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95,212 units
Product Description
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings 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.
Reason for Recall
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Distribution Pattern
Worldwide distribution.
Code Information
All devices are affected