Pentax Medical Video Processor; Model Number: EPK-i8020c;

FDA device recall Z-2329-2025 · posted 2025-08-15 · Open, Classified

Recall details

Recalling firm

Pentax of America Inc

Reason for recall

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.

Action taken

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 customeradvisories@pentaxmedical.com. Contact Information: Please indicate through the attached response form that you have received and understood this information, by completing it and returning it no later than July18, 2025 at: customeradvisories@pentaxmedical.com If you have any questions regarding this action, please feel free to contact us at: " Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) " Fax: (800)-579-5432) " Email: customeradvisories@pentaxmedical.com

Root cause

Device Design

Status

Open, Classified

Product code

PEA

Quantity affected

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.

Date initiated

2025-07-16

Date posted

2025-08-15

Location

Montvale, NJ

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