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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00944-1
Product Name/Description BrightView XCT
(SPECT/CT diagnostic imaging system)

Model Numbers: 882482 and 882454

ARTG Number: 117440
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/09/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips received a report from the field that the flat panel detector (FPD) sensor reported to the operator that the panel was unlatched at the 0 degree position during setup. The operator attempted to manually relatch the FPD as it remained in the 0 degree position. In trying to restow the FPD, it fell from its stowed position and contacted the patient's leg and the technologist's arm.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising their customers to only deploy or stow the FPD when in the +90 degrees position. Philips will be implementing a field correction to prevent the issue from occurring.
Contact Information 1800 251 400 - Philips Customer Care Centre