Artis Zee Multi-Purpose and Artis Zee Biplane (2014-09-23)

Starting date:

September 23, 2014

Posting date:

October 2, 2014

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-41641

• 
  Reason
• 
  Affected products

Recalled Products

A) Artis Zee Multi-Purpose

B) Artis Zee Biplane

Reason

Siemens is informing customers regarding a field corrective action for Artis Zee and Artis Zeego systems used in conjunction with the A100 generator and A 3 focal spot X-ray tube from a specific manufacturing lot. Systems with SW versions VC14 and VC21 are potentially affected. The so-called "small focus" of A3 focal spot X-ray tube may sporadically fail and under certain circumstances further radiation release won't be possible any longer. In this case, the two remaining focal spots ("large focus" and "micro focus") however will still be operational without any restriction. This is a sporadic but not a systematic failure.

Affected products