bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vyaire Medical
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
Product Codes/Lot Numbers:
UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1966-2023
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