Pentax recalls 9310HD Digital Video Capture Modules with software version 3.4.0+ that may copy exam videos 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.
Pentax is recalling certain 9310HD Digital Video Capture Modules with software version 3.4.0 or higher that could copy exam videos from one patient to another during follow-up reviews. This risk only appears after initial review and during later checks, potentially causing patient privacy issues.
The software issue causes exam videos for one patient to be copied to another patient's record during follow-up reviews. This error only occurs after the initial review and when the system is checked later, not during the first use.
Healthcare providers using Pentax 9310HD systems with software version 3.4.0 or higher are most at risk. Patients are not directly affected but could experience privacy concerns if videos are misassigned.
Check if your Pentax 9310HD system has software version 3.4.0 or higher and is configured with the 9263 endoPortal. Affected units have specific computer serial numbers listed in the recall notice.
Verify your system's software version and endoPortal configuration to determine if it matches the recalled specifications.
No, the recall does not involve physical harm. The risk is limited to potential video mix-ups between patients during follow-up reviews, which could affect privacy but not cause injury.
Check if your Pentax 9310HD has software version 3.4.0 or higher configured with the 9263 endoPortal, and verify your computer serial number against the list provided in the recall notice.
No action is needed if your system does not match the recalled specifications or software version.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-0293-2021 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-0293-2021 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
