Somatom Definition Systems (2013-12-10)

Starting date:

December 10, 2013

Posting date:

February 3, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-37567

• Reason
• Affected products

Recalled Products

1. Somatom Definition - Main Unit
2. Somatom Definition AS - Main Unit
3. Somatom Definition Edge System - CT System
4. Somatom Definition Flash System - Main Unit

Reason

Somatom Definition CT systems running software version Syngo CT 2012B (VA44) may experience a malfunction which may lead to a system display freeze during interventional procedures.  When the function "auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the CT system image database which may cause a system display freeze to occur. When this happens, normal interaction with the system is no longer possible. No error message is issued and only a system restart resolves the problem.  In case of a sudden system display freeze, the interventionalist will potentially not immediately recognize the malfunction and continue the interventional procedure. In view of the misleading information shown on the display, an injury of the patient cannot be fully ruled out.

Affected products