Company: Human Design Medical LLC
Date of Enforcement Report: 8/1/2018
Class III:

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

Recall Number: Z-2530-2018

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

RECALLING FIRM/MANUFACTURER
Human Design Medical Llc, Boston, MA on 5/8/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
45

DISTRIBUTION
CA, FL, GA, MI, SC, and TX.