FDAJanuary 29, 2025device

Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

What to do

FDA enforcement status: Ongoing

Brands named

pentax

UPCs

04961333247974

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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