11

Mar

2020

Recall – Ventilators experience intermittent failures due to software error

recall, softwareerror

0

Company: Vyaire Medical
Date of Enforcement Report: 2/26/2020
Class II

PRODUCT

Bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.

Recall Number: Z-1337-2020

REASON

The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a ‘no alarm’ condition, or presence of non-responsive touch screen.

RECALLING FIRM/MANUFACTURER

Vyaire Medical on 11/25/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

116

DISTRIBUTION

US Nationwide

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