Home › FUJIFILM CORPORATION › FUJIFILM

FUJIFILM

FUJIFILM CORPORATION · Model WT-04G · UDI-DI 04547410331585

FCX Prescription

510(k) clearances

551

Adverse events (6 deaths)

Recalls

Facilities

Description

This product is intended to be used in combination with the FUJIFILM endoscopic CO2 regulator GW-100, of which the Operation Manual lists the water tank WT-04G as a consumable supply in the “Main Specifications” section. Do not use this product for any other purposes.

Recalls

Date	Firm	Reason
2021-01-15	Northgate Technologies, Inc.	An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
2013-09-16	Pentax Medical Company	PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an end

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 key Read the docs

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.