FDA recall Z-2530-2018

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

Reason for recall

Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

Distribution

US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.

Key facts

Status

Terminated

Initiation date

2018-05-08

Report date

2018-08-01

Termination date

2020-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2018