medical Class II Updated 2020-11-04

Pentax of America Inc recalls 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

Recalled Product

9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All systems with version 1.1.0 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
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