Wednesday, July 21, 2021

Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Issue

This is a Class I recall. Serious injuries may result from the use of these devices.

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FDA - Center for Devices and Radiological Health

Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Issue

Vero Biotech is recalling the GENOSYL DS; Nitric Oxide Delivery System due to a software issue that leads to errors in the delivery of nitric oxide. This could lead to serious adverse events such as drops in oxygen level and heart problems.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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Questions?

If you have questions about this recall, contact the Division of Industry and Consumer Education.


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