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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