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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00212-1
Product Name/Description Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CT

Software release versions between 4.0.0 and 4.1.2 inclusive

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/03/2015
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue It is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image.
The following key events must take place for harm to occur:
- The patient is placed in a “feet-first” orientation.
- An interventional CT procedure is scheduled.
- Contrary to typical clinical practice, a Multi-Planar Reconstruction (MPR) is used for planning the interventional procedure (this issue only occurs in images produced using MPR).
- A check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).-
- The needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location).
Recall Action Recall for Product Correction
Recall Action Instructions Philips is advising their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A software update will be implemented to correct the issue. This action has been closed-out on 4/08/2016.
Contact Information 1800 251 400 - Philips Customer Care Centre