Recall – Continuous Ventilator, Cl III Vivo 65

Company:Human Design Medical Llc
Date of Enforcement Report 8/1/2018
Class lII:

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.

___________________________________

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.