[Recalled] Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. — Error in the device firmware results in the inaccurate detection of device posi… | FDA 2021-09-07
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. |
|---|---|
| Brand / manufacturer | NOX MEDICAL |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0031-2022 |
| Country of notice | Iceland |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 07 September 2021 |
| EAN / barcode | 15694311111443 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Error in the device firmware results in the inaccurate detection of device position.
This Class II recall concerns device products distributed in Iceland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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