Reported Aug 1, 2018 · Terminated
Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent…
Human Design Medical LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Human Design Medical Llc · 119 Braintree St Ste 703 · Boston, MA · 02134-1642
Is this the product you have?
- Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000
- Product UsageTo provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
- Lot codes and dates
- Pending
- Amount recalled
- 45
Where it was sold
Why it was recalled
Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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