OFFICIAL-SOURCE RECALL · AUSTRALIA
Philips iCT, Ingenuity CT, and Brilliance CT 64 systems Recall: Classification Class II Reason for the
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Why this product was recalled
Classification Class II Reason for the Action During the cardiac scan planning, if the X (XCA, XCB, XCC, XCD) filter for reconstruction is selected, the reconstructed cardiac images may display unexpected noise. Noisy cardiac images may result in reduced image quality, including recognisable artifacts, anatomy obscured by artifacts, or non-diagnostic images. To date Philips has not received any reports of injury or patient harm associated with this problem Instructions for Customers/Users Customers may continue to use system(s) in accordance with the intended use. Users may use alternative CA, CB, CC, and CD filters and evaluate the image quality during live planning or during offline reconstruction. Philips will
Hazard
Classification Class II Reason for the Action During the cardiac scan planning, if the X (XCA, XCB, XCC, XCD) filter for reconstruction is selected, the reconstructed cardiac images may display unexpected noise. Noisy cardiac images may result in reduced image quality, including recognisable artifacts, anatomy obscured by artifacts, or non-diagnostic images. To date Philips has not received any reports of injury or patient harm associated with this problem Instructions for Customers/Users Customers may continue to use system(s) in accordance with the intended use. Users may use alternative CA, CB, CC, and CD filters and evaluate the image quality during live planning or during offline reconstruction. Philips will
Official recall notice
Philips iCT, Ingenuity CT, and Brilliance CT 64 systems
Agency: Therapeutic Goods Administration
Official publication date: January 4, 2010
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