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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901026 · UDI-DI 00732094016451

ERA Prescription
10
510(k) clearances
23
Adverse events
1
Recalls
234
Facilities

Description

Welch Allyn 3.5 V Halogen HPX Ophthalmic Set including PanOptic Ophthalmoscope with Cobalt-Blue Filter on Corneal Viewing Lens (#11820), Prestige Coaxial-Plus Ophthalmoscope (#11735), Elite Streak Retinoscope (#18245), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 120-Minute Power Handle(s), Hard Storage Case, Training Fundus Eyebox (#SM2383), Fixation Cards, Charging Well Adapter; Lithium-Ion (#71960) Battery; IEC Plug Type-A

Recalls

DateFirmReason
2025-05-09Baxter Healthcare CorporationThe replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to ex

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Data 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.