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Pentax medical video processors
Official notice
28 Feb 2025
Last checked
28 Feb 2025
An official Health Canada notice concerns Pentax medical video processors. Under certain conditions, during endoscopic procedures using a combination of the Pentax Medical Video Processor EPK-I8020C and the Pentax Medical Video Upper GI Scope EG29-I20C, the observed image can become reddish or dark. Globally, Pentax has received 32 complaints related to this issue. The 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. These phenomena occur when substances such as mucus and blood attached to the light guide (illumination part) at the distal end of the endoscope absorb the illumination light from the light source to the maximum extent, causing it to heat up and coagulate. They are more likely to occur in OE (optical enhancement) mode but have also been observed with white light. Although the existing instructions for use already include cautionary statements to contemplate the risk of harm observed, Pentax Medical is issuing this customer communication to further reduce the potential health risk. Recall start date: February 18, 2025 Published 2025-02-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77039
Official notice
2025-02-28
The hazard
The hazard
Under certain conditions, during endoscopic procedures using a combination of the Pentax Medical Video Processor EPK-I8020C and the Pentax Medical Video Upper GI Scope EG29-I20C, the observed image can become reddish or dark. Globally, Pentax has received 32 complaints related to this issue. The 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. These phenomena occur when substances such as mucus and blood attached to the light guide (illumination part) at the distal end of the endoscope absorb the illumination light from the light source to the maximum extent, causing it to heat up and coagulate. They are more likely to occur in OE (optical enhancement) mode but have also been observed with white light. Although the existing instructions for use already include cautionary statements to contemplate the risk of harm observed, Pentax Medical is issuing this customer communication to further reduce the potential health risk. Recall start date: February 18, 2025
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
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Company & contacts
Company & contacts
Brand: Hoya, Pentax Medical Video Processors.
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Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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