The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1967-2023·Announced 2023-06-21

bellavista 1000e Ventilator Software May Hang, Affecting Device Interface

Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 Class II recall with no reported illnesses, injuries, or hospitalizations. The identified risks—application hang and potential operator use error—represent real hazards but have not resulted in documented patient harm, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Vyaire Medical is recalling the bellavista 1000e Ventilator (Catalogue Number 301.100.130) and bellavista 1000 models with Software Version 6.1.0.2 and 6.1.1. Approximately 392 units were distributed nationwide in the United States. The recalled ventilators can be identified by UDI/DI codes 07640149381115 and 07640149388879 or by serial numbers with the specified software versions.

The recall addresses two identified patient safety risks. First, under certain conditions of use, the device touchscreen may become unresponsive and the application may stop responding. When this occurs, an error message stating "DeviceSoftware.Application is not responding" or a decommission screen will appear, and the ventilator will issue both audible and visual alarms. Importantly, ventilation continues without interruption with the settings that were in place before the application stopped responding.

Second, there is potential for a use error if an operator applies the ventilator's proposed settings without first confirming that those settings are suitable for the specific patient. This represents a theoretical risk if proper operational procedures are not followed.

The recalled product

Product
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Manufacturer
Vyaire Medical
Category
Medical Device — Mechanical Ventilator
Hazard
Affected units
392

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 07640149381115 and 07640149388879
  • ALL serial numbers with Software Version 6.1.0.2 and 6.1.1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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