Device product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Z-0498-2020
Product summary
- Event
- Event 84115
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,749 Units
- Official record key
device-enforcement:Z-0498-2020
Official wording
Reason: 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.
Code information: All units manufactured prior to 1 May 2017.
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
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.