PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 5, 2025 Initiated: January 29, 2025 #Z-1238-2025

Product Description

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

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.

Details

Recalling Firm
Pentax of America Inc
Units Affected
94 units
Distribution
Nationwide
Location
Montvale, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Pentax of America Inc. Units affected: 94 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1238-2025.