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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901074 · UDI-DI 00732094080384

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Welch Allyn 6.0 V Illumination System for Disposable Endoscopes; Insufflation Bulb (#30200), Fiber-Optic Light Head (#36019), Light Handle with 3.0 ft/0.9 m Cord (#73211), Power Transformer with 5.0 ft/1.2 m Cord; 120 V, 60 Hz AC, IEC Plug Type-B

Recalls

Date	Firm	Reason
2016-04-06	Pentax Medical Company	Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the U
2016-04-06	Pentax Medical Company	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

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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.