9372HD Digital Capture — Class II medical device recall Z-0292-2021
Terminated recall by Pentax of America Inc, reported 2020-11-04, distributed nationwide. There is an intermittent software issue that could affect the systems, in which an exam video for one patient
| Recall number | Z-0292-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2020-09-22 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2022-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 39 total |
| Reason classes | software |
| Serial numbers | 81536-06, 81536-12, 81538-05, 84086-01, 84087-03, 84087-04, 84087-06, 84088-11, 84088-13, 84088-14, 84089-02, 84089-03, 84089-06, 84089-12, 84089-13, 84089-16, 84090-02, 84090-06, 84090-08, 84090-09, 84090-10, 84090-11, 84090-14, 84090-15, 84090-16 and 14 more |
Product
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0292-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.