Pentax of America Inc: Medical Device Recall in 2020 - (Recall #: Z-0292-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 22, 2020

Date Posted: November 4, 2020

Recall Number: Z-0292-2021

Event ID: 86440

Reason for Recall:

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.

Status: Terminated

Product Quantity: 39 total

Code Information:

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

Distribution Pattern:

US Nationwide and Canada

Voluntary or Mandated:

Voluntary: Firm initiated