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

FDA device recall Z-0293-2021 · posted 2020-10-23 · Terminated

Recall details

Recalling firm

Pentax of America Inc

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.

Action taken

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 vigilance@pentaxmedical.com. 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: customeradvisories@pentaxmedical.com. 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

Root cause

Software design

Status

Terminated

Product code

OUG

Quantity affected

39 total

Distribution

US Nationwide and Canada

Date initiated

2020-09-22

Date posted

2020-10-23

Date terminated

2022-05-16

Location

Montvale, NJ