Device product
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Z-0293-2021
Product summary
- 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
software issue