Z-2530-2018 Class III Terminated
FDA device recall Z-2530-2018 was initiated by Human Design Medical Llc on May 8, 2018 and is designated Class III. Reason for recall: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. The recall status is terminated (terminated May 4, 2020). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- May 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
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 for Recall
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Distribution Pattern
US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Code Information
Pending