Medical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions
PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices 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 a risk-of-harm product (diagnostic medical device) where malfunction could affect test results. Although no illnesses or injuries have been reported, the potential for harm elevates this above precautionary recalls. FDA Class II classification without hospitalization reports prevents a higher severity score.
Plain-English summary
PATH has issued a recall for SENTIERO SCREENING hearing examination devices (Model Number SOH100098, Part Number 100098-S, Serial Number 280117, UDI-DI 04260223142475).
Affected units may experience technical distortions to a greater extent than expected. The recalled devices were distributed to healthcare facilities in Florida, Missouri, Ohio, and Wisconsin.
No illnesses or injuries have been reported in connection with this issue. Healthcare providers and patients who have received or used these devices are advised to contact PATH regarding this recall.
The recalled product
- Product
- SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
- Manufacturer
- PATH
- Hazard
- technical-distortion
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 (2)
- UDI-DI: 04260223142475
- Serial Numbers: 280117
Distribution
Distributed in 4 states:
- FL
- MO
- OH
- WI
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