Vyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures
Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a medical device failure (alarm and touch screen) that poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vyaire Medical is recalling 116 units of the bellavista 1000 ventilator, catalog number 301.100.030. The recall was initiated because the devices may experience intermittent failures, specifically a lack of acoustic high-priority alarms, a 'no alarm' condition, or a non-responsive touch screen.
The affected ventilators were distributed nationwide in the states of Alabama, California, Colorado, Florida, Georgia, Illinois, Maryland, Michigan, Pennsylvania, Texas, Washington, and Puerto Rico. The recall covers specific serial numbers listed in the agency's official documentation.
Consumers and healthcare facilities should stop using the affected ventilators and contact Vyaire Medical for instructions on how to proceed. The company is responsible for managing the recall and providing necessary support to affected users.
The recalled product
- Product
- bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compr
- Manufacturer
- Vyaire Medical
- Category
- Medical Device — Ventilator
- Affected units
- 116
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 (20)
- Serial numbers: MB170104
- MB170118
- MB170151
- MB170202
- MB230000
- MB230020
- MB230024
- MB230027
- MB230031
- MB230033
- MB230035
- MB230036
- MB230037
- MB230038
- MB230039
- MB230040
- MB230041
- MB230046
- MB230048
- MB230049
Distribution
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