The Recall Desk
HighFDA (Devices)·Z-1966-2023·Announced 2023-06-21

bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II with no reported illnesses or injuries. The identified risks (touchscreen malfunction and use error potential) on a critical life-support device qualify it as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Vyaire Medical is recalling the bellavista 1000 Ventilator (Catalogue Number 301.100.030), a continuous-use ventilation device. Approximately 910 units have been distributed nationwide. The recall applies to all serial numbers with Software Version 6.1.0.2 or 6.1.1.

Two safety risks were identified. Under certain conditions of use, the touchscreen may become unresponsive, causing the device application to stop responding (APP Hang). When this occurs, the user interface displays a message stating 'DeviceSoftware.Application is not responding' or a decommission screen, and the ventilator issues both audible and visual alarms. Ventilation continues without interruption with the settings applied prior to the error. Additionally, there is a potential for use error if the operator applies proposed settings without confirming the settings are suitable for the patient.

This recall affects healthcare facilities and other entities using the bellavista 1000 Ventilator with the affected software versions.

The recalled product

Product
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Manufacturer
Vyaire Medical
Category
Medical Device — Ventilator
Hazard
  • app-hang
  • use-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI: 10190752197664 and 07640149381115
  • ALL serial numbers with Software Version 6.1.0.2 and 6.1.1

Distribution

Distributed nationwide across the United States.

Related recalls

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