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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01603-1
Product Name/Description	Philips MX 16-slice CT systems featured with Lung Nodule Analysis Serial numbers: 100006, 200019, 200065, 200001, 200021, 200067, 200002, 200022, 200071, 200009, 200023, 200079, 200011, 200026, 200083, 200014, 200029, 200084, 200016, 200035, 200090, 200017, 200059, 200092, 200018, 200062, 200078 ARTG Number: 158775
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	9/12/2016
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The formula of Doubling Time is incorrectly defined in Lung Nodule Analysis (LNA). This may result in the wrong calculation result of Doubling Time, which may lead to misdiagnosis. LNA is an optional tool that is only featured on MX 16-slice systems with software version 2.0.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips will upgrade the system software and replace the software discs free of change. Before the software is upgraded, customers are advised not to refer to the parameter of “Doubling Time [day]” in Lung Nodule Analysis, instead refer to the parameter “Growth Rate [%]” for the growth of nodules. This action has been closed-out on 22/03/2018.
Contact Information	1800 251 400 - Philips Customer Care Centre