PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery
Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 involves a life-support medical device where a defect could lead to incomplete air delivery, representing a risk of harm. However, the source text does not report any actual injuries, illnesses, or fatalities, and the agency classification is Class II, which aligns with a High severity score for risk-of-harm products without reported injury.
Plain-English summary
Precision Valve & Automation, Inc. is recalling three units of the PVA PREVENT emergency ventilator. This FDA-authorized device is designed to treat patients suffering from COVID-19 respiratory failure by automatically compressing a resuscitator bag to provide air to the lungs. The recall involves specific units identified by Lot # EV123732 and Serial #s L1002, L1005, and L1006.
The recall is due to a potential software error that may occur during the machine's error-checking process for stepper movements and pressure values while in "Run" mode. This unexpected event can result in a false alarm being triggered. In rare cases, it may lead to an incomplete move, which affects the current inhale/exhale cycle and could impact the delivery of air to the patient.
The affected units were distributed worldwide, including nationwide in the United States and in Rwanda. The source text does not specify the exact number of patients affected or report any specific injuries or illnesses resulting from this defect. Users of these specific serial numbers should contact the manufacturer for further instructions on how to proceed.
The recalled product
- Product
- PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and…
- Manufacturer
- Precision Valve & Automation,Inc
- Category
- Medical Device — Ventilator
- Affected units
- 3
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 (3)
- Lot #: EV123732 Serial #s: L1002
- L1005
- L1006
Distribution
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