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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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
Related recalls
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighHamilton G5 Ventilator Recalled for Suctioning Maneuver Software Defect
FDA (Devices) · 2016-05-18
- HighBreas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction
FDA (Devices) · 2015-07-22
- HighVivo 45LS Ventilator processor failure alarm not generated on shutdown
FDA (Devices) · 2022-07-20
- HighHamilton-G5 Ventilators Recalled for Display Freeze Issue
FDA (Devices) · 2015-08-05
- SevereHamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk
FDA (Devices) · 2019-07-17
- SevereVivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk
FDA (Devices) · 2024-09-11