Human Design Medical Llc recalls Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilat…

Recall date

May 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2530-2018

FDA classification

Class III

Brand / firm

Human Design Medical Llc

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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