Home › WELCH ALLYN, INC. › Welch Allyn, Inc.
Welch Allyn, Inc.
WELCH ALLYN, INC. · Model 901035 · UDI-DI 00732094145014
EWO
Prescription
10
510(k) clearances
63
Adverse events
5
Recalls
65
Facilities
Description
Welch Allyn AudioScope 3 Screening Audiometer; Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 110-130 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-B
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2023-09-26 | PATH | Affected lots of product may experience technical distortions to a greater extent than expected. |
| 2008-09-16 | Cardinal Health, Inc | GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.
