| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01226-1 |
| Product Name/Description |
BrightView XCT SPECT/CT systems
Model Numbers: 882482 and 882454
ARTG number: 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified two issues with the BrightView XCT SPECT/CT systems:
1) Whilst performing a clinical SPECT/ CT study on a BrightView XCT SPECT/CT systems, the CT portion of the scan may be interrupted and not complete successfully. This problem is not detectable by the user prior to the interruption of the CT acquisition. Interruption of the CT acquisition portion of the scan may necessitate a re-scan of the interrupted segment, resulting in overall radiation to the patient being higher than planned. The additional radiation would be less than the amount delivered from a single successful scan of that body segment.
2) Investigation of generator faults from the field have identified that the ground connection on the X-Ray generator cabinet may have been wired incorrectly during installation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users of the issue and providing work around instructions should the problem occur.
Philips is also updating the XCT generator configuration to increase tube life and implementing a software update. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |