| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00260-1 |
| Product Name/Description |
Philips BrightView / BrightView X / BrightView XCT and BrightView X upgrade to XCT
(Nuclear medicine gamma camera and SPECT/CT systems)
Model Number and Device Name:
882480 - BrightView
Software versions: 1.2.1, 1.2.2, 1.2.3, 1.2.4 and 1.2.5
Model Number and Device Name:
882478 - BrightView X
882482 - BrightView XCT
882454 - BrightView X upgrade to XCT
Software versions: 2.5.1, 2.5.2, 2.5.3, 2.5.4 and 2.5.5
ARTG Numbers: 117642, 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Several issues have been identified with Philips BrightView, BrightView X and BrightView XCT leading to a need to re-scan the patient:-
BrightView XCT Systems only:
- Motion Controller emits the warning message; and
- Door interlock switch with X Ray perform.
For both BrightView X and XCT Systems:
- Detector contacts head holder when performing Patient Unload
For BrightView, BrightView X, and BrightView XCT systems:
- JETStream Freezes during Gated Planar scan. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is notifying the affected users of these issues via this Customer Information Letter. Customers will be contacted by a Philips Field Service Engineer for implementation of the necessary software corrections free of charge.
This action has been closed out on the 12/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |