Medical Device Recall: 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
Pentax of America Inc · January 29, 2025
Reason for Recall
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.
Distribution
Nationwide
States Affected
NATIONWIDE
Quantity Affected
94 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1238-2025
Status: ongoing
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