Medical Device Recall: PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
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
152 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1236-2025
Status: ongoing
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