GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reported: June 30, 2021 Initiated: May 19, 2021 #Z-1863-2021
Product Description
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reason for Recall
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Details
- Recalling Firm
- Vero Biotech, LLC
- Units Affected
- 465 units
- Distribution
- Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860. Recalled by Vero Biotech, LLC. Units affected: 465 units.
Why was this product recalled? ▼
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Critical. Recall number: Z-1863-2021.
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