FDA Medical Device Recalls (openFDA)
Human Design Medical Llc: 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
- Recall number
- Z-2530-2018
- Recalling firm
- Human Design Medical Llc
- 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
- Status
- Terminated
- Initiated
- 2018-05-08
- Posted
- not on file
- Terminated
- 2020-05-04
- Reason
- Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
- Root cause
- Employee error
- Action
- On May 8, 2018, the firm notified all affected customers via phone to quarantine all affected devices. On May 18, 2018, formal Field Safety Corrective Action letters were sent to all affected customers via FedEx. Customers were asked to remove affected units from use and return to the firm, and to complete and return the Acknowledgement and Product Replacement forms. Customers were informed that the firm would be shipping replacement devices.
- Quantity
- 45
- Distribution
- US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
- Lot, serial or model codes
- Pending
- 510(k) numbers
- ["K160481"]
- PMA numbers
- not on file
- Product code
- NOU
- Firm FEI
- 3010817335
- Firm city
- Boston
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28