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Pentax of America Inc recalls 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Recalled November 4, 2020 · FDA recall Z-0293-2021 · Pentax of America
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. · FDA Class II
Units
39 total
Sold at
US Nationwide and Canada
Description
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.
Product
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →