Cios Alpha (2015-05-05)

Starting date:

May 5, 2015

Posting date:

June 1, 2015

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-53523

• Reason
• Affected products

Recalled Products

1. Cios Alpha

Reason

The following user actions may cause the system to freeze and the system may become temporarily inoperable:

• when images were transferred from the left monitor to the right monitor (function A to B) during image acquisition (i.e. radiation on) or shortly before starting image acquisition.
   
• when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress.
   
• when scene replay was initiated either automatically or by pressing the "play" button (especially when pressing the "play" button more than once) while the storing of those scenes was still in progress.
   
• when image acquisition was initiated again before automatic replay of the last scene started.
   
• when finalized CD/DVDs were used to store additional data.
   
• when radiation summary reports with more than 190 entries were being exported.
   
• when system restart was initiated when the error message "system blocked. Turn system off/on" (error codes 215/80 and/or 208/80) was displayed.If a system freeze occurs, a system reset is required to resume fully operation. This process may take approximately 4 minutes. During the reset process no x-ray imaging is available at Cios Alpha mobile C-arm X-ray system.

Affected products