Recall Z-0401-2024— 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, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098. 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, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
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.