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NOX MEDICAL recalls
1 recall recorded since 2018, most recently on 7 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 September 2021
- Terminated
- 1 May 2023
- Reason
- Error in the device firmware results in the inaccurate detection of device position.
- Distribution
- US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0031-2022
- Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.