Pentax Medical Video Processor; Model Number: EPK-i8020c;
Reported: August 27, 2025 Initiated: July 16, 2025 #Z-2329-2025
Product Description
Pentax Medical Video Processor; Model Number: EPK-i8020c;
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.
Details
- Recalling Firm
- Pentax of America Inc
- Units 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.
- Location
- Montvale, NJ
Frequently Asked Questions
What product was recalled? ▼
Pentax Medical Video Processor; Model Number: EPK-i8020c;. Recalled by Pentax of America Inc. Units affected: 144 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2025. Severity: Moderate. Recall number: Z-2329-2025.
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