FDA recall Z-1237-2025

Pentax of America Inc · Class II · device

Product

PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c

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

Key facts

Status
Ongoing
Initiation date
2025-01-29
Report date
2025-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2025