Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0292-2021 — 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

U.S. FDA — Device Enforcement · United States · 2020-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0292-2021
Date of alert
2020-09-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Pentax of America Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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