Z-2530-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- May 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
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
Reason for Recall
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Distribution Pattern
US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Code Information
Pending