Recall Z-0404-2024— PATH
Class II · Ongoing
Class II FDA medical device recall by PATH, initiated 2023-09-26. It names 2 FDA 510(k) clearances: K213345, K133012. Product: SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S. Reason: Affected lots of product may experience technical distortions to a greater extent than expected..
- Recalling firm
- PATH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-26
- Firm location
- Germering, Germany
510(k) clearances named in this recall
2 on FDA's record- K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
- K133012 — SENTIERO
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Reason for recall
Affected lots of product may experience technical distortions to a greater extent than expected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.