Vyaire Medical recalls Bellavista 1000 ventilators with software version 6.1.0.2 or 6.1.1 due to touchscreen unresponsiveness and potential use errors that could affect patient safety.
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.
Vyaire Medical is recalling Bellavista 1000 ventilators with specific software versions because they can become unresponsive, causing alarms but continuing ventilation, and there's a risk of using incorrect settings for patients.
The ventilator's touchscreen may stop responding under certain conditions, showing an alarm but continuing ventilation with previous settings. If settings are applied without confirming they're suitable for the patient, it could lead to incorrect treatment.
Patients using the Bellavista 1000 ventilator with software versions 6.1.0.2 or 6.1.1 are affected. Healthcare providers and patients with respiratory conditions requiring ventilator support are most at risk.
Check for the Bellavista 1000 ventilator with software version 6.1.0.2 or 6.1.1. The device has a specific catalogue number (301.100.030) and serial numbers starting with 10190752197664 or 07640149381115.
Verify the software version on your ventilator; affected units have version 6.1.0.2 or 6.1.1.
Ensure settings are confirmed suitable for the patient before applying them to avoid potential use errors.
Software versions 6.1.0.2 and 6.1.1 are affected.
Check for the Bellavista 1000 ventilator with software version 6.1.0.2 or 6.1.1, and serial numbers starting with 10190752197664 or 07640149381115.
The recall does not specify a fix; users should check software version and confirm settings before use.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1966-2023 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-1966-2023 from Vyaire Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
