Brilliance and Ingenuity CT and ICT System (2016-04-21)

Starting date:

April 21, 2016

Posting date:

May 17, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58356

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  Reason
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  Affected products

Affected products 

1.  BRILLIANCE 40/64 SLICE CT SYSTEM

2. BRILLIANCE ICT SYSTEM - SYSTEM

3. BRILLIANCE ICT SP SYSTEM - MAIN

4. INGENUITY CT SYSTEM

Reason

Philips has become aware of the following seven software issues:  1.Sagittal result shortened for axial scans, 2.Single series displayed in console viewer when creating MPR's., 3. Scan length changes with a change in field of view, 4. Different CTDI values with dose right, 5. Scan length changes on subsequent axial results, 6. Surview scan lengths near 135mm or 184mm may result in unexpected scan start positions, and 7. Reconstruction length does not equal scan length.

Affected products