Vivo 65 — Class III medical device recall Z-2530-2018
Terminated recall by Human Design Medical Llc, reported 2018-08-01, distributed nationwide. Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
| Recall number | Z-2530-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Human Design Medical Llc, Boston, MA, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-07-23 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 45 |
| Reason classes | software |
| Model numbers | 204000 |
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
Reason for recall
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2530-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.