Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
9310HD Digital Video Capture Module with software version 3.4.0 or Recalled by Pentax of America Inc Due to There is an intermittent software issue that could...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pentax of America Inc directly.
Affected Products
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Quantity: 39 total
Why Was This Recalled?
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pentax of America Inc
Pentax of America Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report