Sleep Recording Device with Firmware Error Affecting Position Detection
Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The firmware defect affecting position detection in a diagnostic medical device represents a risk-of-harm product without reported injury, meeting the criterion for Score 3 (High).
Plain-English summary
The Nox T3s Recorder is a medical device intended for ambulatory recording of physiological signals during sleep. A firmware error in affected units results in inaccurate detection of the device's position during recording, which may affect the accuracy of diagnostic information.
The recall involves 128 units distributed nationwide to healthcare facilities in California, Georgia, Illinois, Iowa, Michigan, New Mexico, Ohio, Pennsylvania, and South Dakota. Affected devices can be identified by their serial numbers listed in the FDA recall notice.
Healthcare providers and medical facilities using these devices should contact the manufacturer, NOX MEDICAL, regarding available remedies. Devices should not be used for diagnostic purposes until the firmware error has been corrected.
The recalled product
- Product
- Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
- Manufacturer
- NOX MEDICAL
- Affected units
- 128
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number: 561111
- UDI: (01)15694311111443
- Serial Numbers: 300106423
- 300106426
- 300106420
- 300106419
- 300106422
- 300106427
- 300106425
- 300106424
- 300106421
- 300106477
- 300106485
- 300106783
- 300106806
- 300106841
- 300106843
- 300106846
- 300106848
- 300106852
Distribution
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