Class 3 Device Recall Vivo 65

• Date Initiated by Firm: May 08, 2018
• Create Date: July 23, 2018
• Recall Status: Terminated on May 04, 2020
• Recall Number: Z-2530-2018
• Recall Event ID: 80296
• 510(K)Number: K160481
• Product Classification: Continuous, ventilator, home use - Product Code NOU
• 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
• Code Information: Pending
• FEI Number: 3010817335
• Recalling Firm/ Manufacturer: Human Design Medical Llc; 119 Braintree St Ste 703; Boston MA 02134-1642
• Manufacturer Reason for Recall: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
• FDA Determined 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 in Commerce: 45
• Distribution: US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NOU