Recall Z-0031-2022 ยท MNR Ventilatory Effort Recorder
NOX MEDICAL
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
| Date | Sep 7, 2021 |
| Status | Terminated |
| Reason | Error in the device firmware results in the inaccurate detection of device position. |
| Root cause | Finished device change control |
| Action | Written notification letter titled, "URGENT: Medical Device Recall" was sent to all consignees on 09/07/2021. The letter instructs the consignee to follow the following instructions: "Further distribution or use of the affected devices should cease immediately. Devices should be quarantined pending device firmware update, per the instructions below. Due to the potential of inaccurate position-related reporting of TST, TRT, AHI and REI; studies performed with the affected T3s devices should be reanalyzed to determine if this has clinical impact on the patient diagnoses. A Nox Medical technical |
| Quantity | 128 units |
| Distribution | US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082113 | NOX T3, NOXTURNAL (PC APPLICATION) Nox Medical, Nov 7, 2008 |