Axiom Luminos DRF System - Main Unit and Uroskop Omnia (2013-09-02)

Starting date:

September 2, 2013

Posting date:

October 16, 2013

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-36187

• 
  Reason
• 
  Affected products

Recalled Products

A. Axiom Luminos DRF System - Main Unit

B. Uroskop Omnia

Reason

1.) During a RAD examination with automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality, resulting in the examination needing to be repeated. Statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode. The automatic exposure control is used less frequently with the Uroskop Omnia, therefore, reducing the risk that such malfunction might occur. 

2.) When selecting a tomo ogp, in some cases the Luminos DRF system shows a message "wait for flc" and this state does not change on its own.

3.) Sporadically it may occur that the radiation is not activated and therefore an exposure is performed without radiation. In case of a scan sequence at luminos drf the complete sequence might have to be repeated.

Affected products