Recall – Continuous Ventilator

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.

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.

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Corporate Office

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