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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