Kay Pentax Stroboscopy System (2020-09-11)

Starting date:

September 11, 2020

Posting date:

September 25, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74001

Last updated: 2020-09-25

• Reason
• Affected products

Affected Products

Kay Pentax Stroboscopy System

Reason

The 9372HD Digital Capture version 1.1.0 or higher and 9310HD Digital Video Capture module with software version 3.4.0 or higher records an exam in separate audio and video files, and then combines these files into a single MP4 file for storage and backup. If a customer uses 9263 endoPortal, it creates a second MP4 file for transfer. When the software recognizes that 9372HD Digital Capture or 9310HD Digital Video Capture module is configured with 9263 endoPortal, it creates a secondary MP4 file for endoPortal and this process gets interrupted intermittently that leads to the first MP4 file to get moved to the exam folder that belongs to the wrong patient. That issue results in the wrong video file being played back under the wrong patient in the exam software.

Affected products