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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00233-1
Product Name/Description Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)

PET/CT System Model Number: 882442

MSD Serial Number: 2090

ARTG Number: 292543
(Philips Electronics Australia - Combination diagnostic imaging system, PET/CT)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 15/03/2018
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has identified that there may be an issue with acquisition if the Addonics Mass Storage Device (MSD) provided with the system is connected to the console and powered on during an acquisition.
Following a period of inactivity, the Addonics MSD may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding resulting in a potential re-scan being required.
Recall Action Product Defect Correction
Recall Action Instructions Philips is advising users to not view studies or access data on the Addonics MSD while a patient is being scanned.

If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable.

It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off.

Philips will be providing an updated Mass Storage Device to all affected customer to correct the issue.

This action has been closed out on 19/02/2019
Contact Information 1800 251 400 - Customer Service Support