Company: Pentax of America Inc
Date of Enforcement Report: 11/4/2020
Class II
PRODUCT
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Recall Number: Z-0292-2021
REASON
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.
RECALLING FIRM/MANUFACTURER
Pentax of America Inc. on 9/22/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
39 total
DISTRIBUTION
U.S. Nationwide and Canada