Vyaire Medical Ventilators Recalled Due to Potential Ventilation Failure
Vyaire Medical is recalling 4,189 bellavista 1000 and 1000e ventilators worldwide due to potential cessation of ventilation under specific conditions. This FDA Class I recall poses serious risk to patients who depend on these critical care devices.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I classification establishes a minimum severity score of Severe (4) per the rubric rules. Class I designation indicates the FDA has determined that use poses a reasonable probability of serious adverse health consequences. The hazard—potential cessation of ventilation in life-critical respiratory support devices—directly threatens patient safety.
Plain-English summary
Vyaire Medical is recalling bellavista 1000 ventilators (Catalog #301.100.030) and bellavista 1000e ventilators (Catalog #301.100.130) due to the potential for cessation of ventilation under specific conditions.
The ventilators are designed to provide positive pressure ventilatory support to adult and pediatric patients, and optionally to infant and neonatal patients. Approximately 4,189 units are affected by this recall.
Affected devices can be identified by the UDI numbers: 07640149381115 (bellavista 1000) or 07640149388879 (bellavista 1000e). Recalled units have Hardware generation G6 and software version V6.0.1600.0 or higher installed. The devices have been distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries.
Healthcare facilities using affected units should contact Vyaire Medical or the FDA for guidance on replacement or remediation.
The recalled product
- Product
- bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients.
- Manufacturer
- Vyaire Medical
- Hazard
- Affected units
- 4,189
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)
- Hardware generation G6
- software version V6.0.1600.0 or higher installed
Distribution
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