FDA Device recall Z-0292-2021
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal)
- FDA Device
- Class II
- terminated
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal) by Pentax, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0292-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-22 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pentax |
| Distribution | US |
Product
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
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.
Identifiers
| code_info | All systems with version 1.1.0 or higher; Computer Serial Numbers: 84086-01 84533-01 84090-16 84090-15 84090-14…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2021%22
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