Merge PACS (2020-08-03)

Starting date:

August 3, 2020

Posting date:

August 28, 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-73781

Last updated:
2020-08-28

• 
  Reason
• 
  Affected products

Affected Products

Merge PACS

Reason

• Issue 1: pixel value measurements from the probe, ROI, and region analysis area tools are incorrect on multi-planar reformats (mprs) generated by Merge PACS.
• Issue 2: black dots may be displayed in a scattered pattern throughout images.
• Issue 3: software correction to address a incorrect part number reference on the about screen of software version 8.1.2 (References part number for v8.1.1).

Affected products