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Human Design Medical Llc recalls Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent venti
Recalled August 1, 2018 · FDA recall Z-2530-2018 · Human Design Medical
Hazard
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. · FDA Class III
Units
45
Sold at
US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Description
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
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
Manufacturer(s)
Human Design Medical Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →