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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00891-1
Product Name/Description Ingenuity TF PET/CT

Model number 882456
Software version: 4.0.0.26636 04-Jan-2013
Serial numbers: 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019
ARTG number: 118077
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/08/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Three issues were identified that may cause a situation requiring a patient rescan:
1. After a surview and low dose CT scan, the system does not show the "Enable" button prompt to allow the user to begin the PET scan resulting in the inability to perform the PET scan.
2. When navigating to the Series field value within the Scan Parameters pane, the Series field value will accept certain characters resulting in the failure of the system to properly process the data and provide a reconstructed image.
3. A PET reconstruction failure as a result of an incomplete study.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare will be installing a software update v 4.0.3. Until software is upgraded, Philips Healthcare advises users to perform workarounds identified in letter.
Contact Information 1800 251 400 - Philips Customer Care Centre