Recall Z-1236-2025 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Pentax of America Inc
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
| Date | Feb 26, 2025 (initiated Jan 29, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | Pentax issued URGENT i20c Endoscope User Notification-Precautions when using PENTAX Medical i20c endoscopes with EPK-i8020c Processor Letter on 1/29/25 certified USPS Mail. The letter states reason for recall, health risk and action to take: Customer Instructions: Perform a pre-use inspection according to the Instructions for Use to make sure that there are no foreign objects, scratches, chips, or other abnormalities on the light guide. Do not use OE (Optical Enhancement) mode in cases where there is bleeding such as hematemesis or hematochezia, or where a lot of bleeding was observed during |
| Quantity | 152 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonosco Pentax of America, Inc., Jul 28, 2023 |