Recall Z-1863-2021 ยท MRN Apparatus, Nitric Oxide Delivery
Vero Biotech, LLC
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
| Date | Jun 23, 2021 (initiated May 19, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | The firm initiated their recall by visit on 04/07/2021. VERO Clinical Educators are going (or have gone) onsite to the hospitals to physically upgrade the software to v2.2.4. The correction of upgrading the software from v2.2.3 to v2.2.4 began on Wednesday April 7, 2021. The software upgrade is expected to be completed by Friday April 23, 2021. For questions contact VERO Biotech at 1-877-337-4118 or visit the VERO Biotech website at https://www.vero-biotech.com/. |
| Quantity | 465 units |
| Distribution | Distributed nationwide to TX, MD, VA, GA, FL, KS, LA, MN, and NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.