Recall Z-2530-2018 ยท NOU Continuous, Ventilator, Home Use
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
| Date | May 8, 2018 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160481 | Vivo 60 Breas Medical AB, Nov 9, 2016 |