Recall Z-0029-2026 ยท MRN Apparatus, Nitric Oxide Delivery
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
| Date | Oct 6, 2025 (initiated Sep 9, 2025) |
| Status | Open, Classified |
| Reason | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. |
| Root cause | Software design |
| Action | On September 9, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers: Actions to be taken: - Customers should ensure that all affected personnel are provided with a copy of the recommendations in this letter. - Users should avoid rapidly pressing buttons in quick succession (e.g., go to next screen, accept a value, change a value, backing out, repeating this) as it is necessary to allow an opportunity for the device to respond to user inputs before the next command to avoid a potential software interruption and subsequent restart. - NOxBOX Ltd. is asking customers in the U.S. t |
| Quantity | 1667 units |
| Distribution | Domestic: TN; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171696 | NOxBOXi Nitric Oxide Delivery System Praxair Distribution, Inc., Oct 2, 2018 |
| K201339 | The NOxBOXi Nitric Oxide Delivery System Praxair, Inc., Jun 19, 2020 |
| K220898 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., Apr 27, 2022 |
| K231823 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., Aug 11, 2023 |
| K233251 | NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment, Inc., May 23, 2024 |