Pentax of America Inc recalls Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic…
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…
Read the official notice →- Date
- 2025-03-05
- Country
- United States
- Brand
- Pentax
- Product
- Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic…
- Classification
- Class II
- Units
- Nationwide
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Pentax recalls
- 2025-08-27
USPentax of America Inc recalls Pentax Medical Video Processor; Model Number: EPK-i8020c;
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…
FDA · DevicePentax of America IncUS Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO,…Official notice →
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