| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00210-1 |
| Product Name/Description |
Philips BrightView XCT and Philips BrightView X to XCT Upgrade Kit
Model Numbers: 882482 and 882454
All software versions
ARTG Number: 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
9/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the intended use statement listed in the Instructions For Use (IFU) is stated incorrectly. A revision of the IFU with amendments (specifically regarding the functional capabilities of the system) will be released. The amended intended use in the IFU is as follows:
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medical images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localisation of the nuclear medicine data. The BrightView XCT imaging system should be used only by trained healthcare professionals. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to be aware of the updated "Intended Use Statement" highlighted in the Customer Information Letter Users are further advised to continue using the system according to their training.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |