I-VIEW (2018-11-27)

Starting date:

November 27, 2018

Posting date:

January 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68640

• 
  Reason
• 
  Affected products

Affected products

I-VIEW

Reason

A field correction has been initiated for I-View Contrast Enhanced Digital Mammography due to a calibration issue that could impact contrast enhancement throughout the subtracted image. This may have an impact on contrast uptake visibility throughout the subtracted image. The mammography system needs to be recalibrated to ensure adequate visibility of the contrast

Affected products