Boston, MA, United States
Human Design Medical Llc recalls
1 recall recorded since 2018, most recently on 8 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 8 May 2018
- Terminated
- 4 May 2020
- Reason
- Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
- Distribution
- US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2530-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.