[pending] MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
Pending LLM rewrite. Source: FDA_DEVICE Z-0940-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.
The recalled product
- Product
- MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
- Manufacturer
- PATH
- Category
- Medical Device — Devices
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)
- Part Number: 8-69-41100
- UDI-DI: 04260223141355
- Serial Numbers: 1008852
- 1008888
- 1008916
- 1008925
- 1008935
- 1008945
- 1008951
- 1008957
- 1008960
- 1008962
- 1008966
- 1008967
- 1008987
- 1008990
- 1009054
- 1009065
- 1009066
- 1009131
Distribution
Distributed in 1 state:
- WI
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