FDA recall Z-0293-2021

Pentax of America Inc · Class II · device

Product

9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

Reason for recall

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.

Distribution

US Nationwide and Canada

Key facts

Status: Terminated
Initiation date: 2020-09-22
Report date: 2020-11-04
Termination date: 2022-05-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2021