Z-0498-2020 Class II Terminated
FDA device recall Z-0498-2020 was initiated by Philips North America, LLC on October 16, 2019 and is designated Class II. Reason for recall: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device… The recall status is terminated (terminated November 29, 2023). Affected quantity: 23,749 Units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 16, 2019
- Termination Date
- November 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,749 Units
Product Description
HeartStart XL+ Defibrillator/Monitor, Model 861290
Reason for Recall
The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: 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.
Distribution Pattern
US Nationwide
Code Information
All units manufactured prior to 1 May 2017.