Health product recall

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

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

Kay Pentax Stroboscopy System

Lot or serial number
  • 84091-16
  • 84533-11
  • 84533-12
Model or catalog number

9372HD

Companies
Manufacturer

Pentax of America, Inc.

3 Paragon Drive

Montvale

07645

New Jersey

UNITED STATES