FDA-Device2020-11-04Class II
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Pentax of America Inc
Hazard
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.
Sold states
US Nationwide and Canada
Affected count
39 total
Manufactured in
3 Paragon Dr, N/A, Montvale, NJ, United States
Products
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2021Don't want to check this manually?
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