Device product
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Z-2530-2018
Product summary
- Event
- Event 80296
- Status
- Terminated
- Classification
- Class III
- Quantity
- 45
- Official record key
device-enforcement:Z-2530-2018
Official wording
Reason: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Code information: Pending
Distribution pattern: US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Derived failure modes
-
Unknown
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.