Lower riskMedical device recall · FDA · Published September 22, 2020
Pentax 9372HD Digital Capture Software Issue: Patient Video Copy Risk
Pentax recalls 9372HD Digital Capture systems with version 1.1.0+ where exam videos could be copied between patients during follow-up reviews. Affected units have specific computer serial numbers listed.
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.
Take action
Contact the company
📍Recalling firmPentax of America Inc3 Paragon Dr · Montvale, NJ 07645-1782
“Pentax 9372HD Digital Capture Software Issue: Patient Video Copy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64230-pentax-9372hd-digital-capture-software-issue-patient-video-copy-risk. Based on FDA recall #Z-0292-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2021%22&limit=1).
Pentax of America Inc recalled 9372HD Digital Capture systems with version 1.1.0 or higher due to a software issue that could copy one patient's exam video to another, according to the FDA. The agency announced the recall on September 22, 2020.
How to tell if you have it
Brand: Pentax
Product: 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal)
The FDA stated 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.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since 2017-07-13. Recent brand recalls include the Pentax EPK-i8020c Medical Video Processor Recall (2025-07-16) and the Pentax Medical Video Upper GI Scope Recall (2025-01-29). Other recent recalls of similar products include the Siemens LUMINOS Q.namix R X-Ray System Recall (2025-12-29), the Siemens LUMINOS Q.namix T X-Ray System Recall (2025-12-29), and the Philips Azurion X-Ray System Recall (2026-06-17).
How to tell if you have this one
Check if your Pentax 9372HD Digital Capture system has version 1.1.0 or higher. Affected units have specific computer serial numbers listed in the recall.
Brand
Pentax
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide and Canada
Recall number
Product, codes & lots
Z-0292-2021
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),; 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
Z-0293-2021
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal; 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
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your system's software version is 1.1.0 or higher to determine if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0292-2021 (September 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0292-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.