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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