Recall Z-2329-2025 ยท PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
Pentax of America Inc
Pentax Medical Video Processor; Model Number: EPK-i8020c;
| Date | Aug 15, 2025 (initiated Jul 16, 2025) |
| Status | Open, Classified |
| Reason | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. 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 membrane. |
| Root cause | Device Design |
| Action | On 7/16/2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Customer Instructions: PENTAX Medical will conduct the software update on the affected devices at your facility. Your local PENTAX Medical representative will contact you to schedule the required updates for your equipment. " Please download the Instructions for Use (IFU) for the EPK-i8020c Video Processor from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com. " Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX Medical at customera |
| Quantity | 144 units |
| Distribution | US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA. |
| FDA record | Open on fda.gov |