bellavista 1000 Ventilator recall: Software Issue
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Why was bellavista 1000 Ventilator recalled?
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
- Product
- bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
- Recalling firm
- Vyaire Medical
- Quantity
- 910 units
- Distribution
- US Nationwide Distribution
- Recall date
- June 21, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)