Human Design Medical Llc: Medical Device Recall in 2018 - (Recall #: Z-2530-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class III

Date Initiated: May 8, 2018

Date Posted: August 1, 2018

Recall Number: Z-2530-2018

Event ID: 80296

Reason for Recall:

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

Status: Terminated

Product Quantity: 45

Code Information:

Pending

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated