Medical Device Screening Tool Recalled Due to Technical Distortion Issues
PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.
What this means for you
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: This is an FDA Class II medical device recall. The device is used for hearing diagnostic screening, and technical distortions could result in incorrect diagnostic results. This constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
PATH is recalling 28 units of SENTIERO Screening2, a mobile medical device used for hearing examinations (Model Number SOH100098, Part Number 100098-S2). The recall was initiated because affected units may experience technical distortions to a greater extent than expected.
The affected devices were distributed to facilities in Florida, Missouri, Ohio, and Wisconsin. Specific serial numbers are 290402-290403, 290405-290408, 290422-290433, 290435-290443, and 290446.
If you have a SENTIERO Screening2 device with one of these serial numbers, contact PATH or the FDA to determine whether your device is affected. Do not use the device if you suspect it may be affected by this issue.
The recalled product
- Product
- SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
- Manufacturer
- PATH
- Hazard
- device-malfunction
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 (6)
- UDI-DI: 04260223145377
- Serial Numbers: 290402-290403
- 290405-290408
- 290422-290433
- 290435-290443
- 290446
Distribution
Distributed in 4 states:
- FL
- MO
- OH
- WI
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