Human Design Medical Recalls Vivo 65 Ventilators Due to Firmware Issue
Human Design Medical is recalling 45 Vivo 65 home ventilators because some devices have an unreleased version of the Firmware upgrade tool.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a software/firmware defect without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Human Design Medical Llc is recalling 45 units of the Vivo 65 Continuous Ventilator, Home Use, Catalog No. 204000. The recall was initiated because some of the devices contain an unreleased version of the Firmware upgrade tool.
The affected devices were distributed nationwide in the states of California, Florida, Georgia, Michigan, South Carolina, and Texas. The product is used to provide continuous or intermittent ventilatory support for individuals who require mechanical ventilation.
Consumers who have this product should contact Human Design Medical Llc for instructions on how to proceed. The specific lot or code information is currently pending.
The recalled product
- Product
- Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
- Manufacturer
- Human Design Medical Llc
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 45
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 (1)
- Pending
Distribution
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