Signa HDXT 1.5T MR System

Starting date:

May 17, 2013

Posting date:

June 17, 2013

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-34203

• Reason
• Affected products

Recalled products

1. Signa HDXT 1.5T MR System

Reason

For Clariview and Screen Save from GVTK (Gems Visualization Toolkit) viewer, the MR product can generate image headers with nonunique series identifiers, which when exported to some PACS systems, results in the series being associated with the incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct. The issue may result in an incorrect diagnosis from the study with mixed patient data, if the series protocol and anatomy on the studies are similar, and the annotation is not noticed. The conditions under which the issue is known to be possible require that the studies have identical time of day (identical hours, minutes, and seconds) and that the exams be on an affected model of PACS at the same time. This is possible with one scanner on different days or on different scanners on the same day.

Affected products