FDAClass IIIAugust 1, 2018

Vivo 65 recall

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of…

Why was Vivo 65 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Pending

Product
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of…
Recalling firm
Human Design Medical Llc
Quantity
45
Distribution
US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Recall date
August 1, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls