Reported Oct 13, 2021 · Terminated
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Nox Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NOX MEDICAL · Keldnaholt · Reykjavik · N/A
Is this the product you have?
- Nox T3s Recorder - Product Usageintended for ambulatory recording of physiological signals during sleep
- Lot codes and dates
- Catalog Number561111
- UDI(01)15694311111443
- Serial Numbers
128 of 128 codes
300106423300106426300106420300106419300106422300106427300106425300106424300106421300106477300106485300106783300106806300106841300106843300106846300106848300106852300106853300106857300106862300106881300106882300106883300106884300106885300106886300106888300106889300106890300106894300106897300106912300107004300106385300106396300106397300106407300106413300106414300106399300106415300106416300106475300106476300106483300106486300106494300106534300106537300106538300106544300106545300106547300106548300106552300106648300106658300106675300106677
- Amount recalled
- 128 units
Where it was sold
Why it was recalled
Error in the device firmware results in the inaccurate detection of device position.
This product could cause temporary or reversible health problems — stop using it.
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