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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00588-1
Product Name/Description Allura Systems: FD10, FD20, FD10/10, Allura Systems with OR table: FD10, FD10/10, FD20/20 (Fluoroscopic x-ray systems used for diagnostic/interventional procedures in cardiovascular and vascular imaging applications)

Product codes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025

Applies to:
Actuator Short Assy: 989600-184-665
Actuator Long Assy: 989600-184-654

ARTG number: 98560, 175708
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/06/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has received reports of occurrences where the monitor ceiling suspension (MCS) system fell to its lowest position due to an assembly error of the MCS Actuator. In one occasion it collided with the table top.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is issuing work around instructions as a temporary measure. The affected MCS actuators will be replaced as a permenant fix.
Contact Information 1800 251 400 - Philips Customer Care Centre