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Terminated

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

FDA Recall Z-2530-2018 · Posted None

Recalling FirmHuman Design Medical Llc
Recall StatusTerminated
Product CodeNOU
Date Initiated2018-05-08
Date Terminated2020-05-04
Product Quantity45

Reason for Recall

Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.

Firm 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.

Root Cause

Employee error

Distribution Pattern

US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160481Vivo 60Breas Medical AB · 2016-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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