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Recall Observatory FDA recall evidence

Device product

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

Z-0293-2021

September 22, 2020

Class II

Product summary

Firm
Pentax of America Inc
Event
Event 86440
Status
Terminated
Classification
Class II
Quantity
39 total
Official record key
device-enforcement:Z-0293-2021

Official wording

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.

Code information: All systems with version 3.4.0 or higher; Computer Serial Numbers: 84086-01 84533-01 84090-16 84090-15 84090-14 84090-11 84090-09 84090-10 84090-08 84088-13 84088-11 84528-08 84087-06 84087-03 84538-06 84088-14 84089-02 84089-06 84089-03 84529-04 84528-05 81536-06 84091-01 84089-16 81536-12 84532-11 81538-05 84090-02 84089-13 84089-12 84090-06 84087-04 84531-12 84531-11 84531-10 84531-13 84091-16 84533-11 84533-12

Distribution pattern: US Nationwide and Canada

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue