FDA Device recall Z-2530-2018
Vivo 65, Continuous Ventilator, Home Use, Cat
- FDA Device
- Class III
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class III recall of Vivo 65, Continuous Ventilator, Home Use, Cat by Human Design Medical, citing some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2530-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-05-08 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Human Design Medical |
| Distribution | US |
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
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Identifiers
| code_info | Pending |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2530-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.