Hydra Vision Urology System and Direct Digital Imaging System (2018-10-07)

Starting date:

October 7, 2018

Posting date:

December 10, 2018

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-68562

• 
  Reason
• 
  Affected products

Affected products

A. Hydra Vision Urology System

B. Direct Digital Imaging System

Reason

Sedecal, the generator manufacturer, created a software algorithm to estimate and display the approximate dose of radiation delivered. Since the device is designed to deliver 50% less radiation when placed in child/pediatric mode, a separate algorithm had to be developed to display this lesser amount. Although the generator's radiation output in all modes was as intended and within specification, when placed in child/pediatric auto-exposure mode, the software selected the adult display algorithm instead of the child/pediatric display algorithm, resulting in a console display reading that was higher than what was actually delivered.

Affected products