Z-0293-2021Class II

9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

Name: Z-0293-2021 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Creator: Pentax of America Inc
Published: 2020-09-22
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2020-09-22 / Terminated / root cause: software

FDA source

Pentax of America Inc began a recall of 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal on 2020-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0293-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-22
Posted: 2020-10-23
Terminated: 2022-05-16
Recalling firm: PENTAX of America, Inc.
Product: 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Product code: OUG Medical Device Data System
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.
Root cause tag: software
FDA root cause: Software design
Action: URGENT MEDICAL DEVICE CORRECTION notification letters were sent on 9/22/20. Customer Instructions: Enclosed with this letter is a Field Correction Response Form which identifies the serial numbers of the affected products your facility owns. PENTAX Medical will be taking a two step approach to contain and correct the problem. o First, we will contact you to schedule a time for our Field Service to temporarily disable file transfer to endoPortal. o During the time that file transfers to endoPortal are disabled, you can continue to create and save exam video files. When this issue is resolved, all files recorded during that period will be uploaded and will be available for endoPortal. o Second, PENTAX Medical is developing a software solution that will be deployed remotely. We will coordinate all updates with your IT administrator. Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at [email protected]. Contact Information: PENTAX regrets any inconvenience that this action may cause and appreciates your understanding and cooperation. PENTAX will issue additional communications as further information becomes available. Please be assured that maintaining patient safety and quality is our utmost priority. If you have any questions regarding this action, please feel free to contact us at: Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]. An Urgent Medical Device Correction notification letter dated 10/22/20 was sent to customers. This letter is a clarification of and replaces the letter dated September 2, 2020, which you received previously. This letter is to inform you that PENTAX Medical (PENTAX) is conducting a voluntary corrective action of impacted 9372HD Digital Capture version 1.1.0 or higher and 9310HD Digital Video Capture Module with software version 3.4.0 or
Quantity in commerce: 39 total
Distribution: US Nationwide and Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0293-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23
Z-0293-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)