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.
- GENOSYL DS; Nitric Oxide Delivery System
- Model Number: 601588-01
- Serial Numbers: All Devices
- Manufacturing Dates: March 15, 2021 to April 5, 2021
- Distribution Dates: March 15, 2021 to April 5, 2021
- Devices Recalled in the U.S.: 467
- Date Initiated by Firm: April 7, 2021
The GENOSYL DS; Nitric Oxide Delivery System is used to deliver a constant flow of GENOSYL (Nitric Oxide), which is a drug to help open blood vessels and improve oxygen levels in critically ill newborns with respiratory failure. The system consists of a cassette, which contains the drug, and a console. The device is used with a ventilator in hospital or healthcare settings.
Reason for Recall
Vero Biotech is recalling its GENOSYL DS; Nitric Oxide Delivery System due to a software issue that leads to errors in the delivery of nitric oxide. Typically, this issue caused delivery of lower-than-expected dosage of nitric oxide during the transition between primary and backup console. If this happens, this could cause serious adverse events such as drops in oxygen level, heart problems, and clinical instability in the newborn.
There have been 11 complaints, three injuries and no deaths reported for this issue.
Who May Be Affected
- Health care providers who may have access to these devices
- Patients using these devices
What to Do
On Jun 15, 2021, Vero Biotech sent an "Urgent: Medical Device Correction" letter to customers stating the release of Software 2.2.4 will correct the adverse events associated with Software 2.2.3. The letter also gave the following instructions:
- The firm began traveling to consignee sites and repairing consoles on April 7, 2021. Contact the firm if you are unsure whether they have updated your devices' software.
Customers with questions about this recall should contact Vero Biotech at 1-877-337-4118, or visit the website https://www.vero-biotech.com/.
How Do I Report a Problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.