Recall Z-2530-2018— Human Design Medical Llc
Class III · Terminated
Class III FDA medical device recall by Human Design Medical Llc, initiated 2018-05-08, terminated 2020-05-04. It names one FDA 510(k) clearance: K160481. 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. Reason: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool..
- Recalling firm
- Human Design Medical Llc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-05-08
- Terminated
- 2020-05-04
- Firm location
- Boston, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.