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QScreen Set
PATH medical GmbH · Model 101275-AS-HP · UDI-DI 04260223147302
GWJ
Prescription
1
510(k) clearances
119
Adverse events
4
Recalls
57
Facilities
Description
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101315-E QScreen Check Kit P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-06 | PATH | 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 |
| 2019-05-28 | GN Otometrics | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. |
| 2010-06-04 | Natus Medical Inc | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. |
| 2008-10-21 | Intelligent Hearing Systems Corp. | This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.