| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00035-1 |
| Product Name/Description |
BrightView SPECT, BrightView X and BrightView XCT (SPECT/CT diagnostic imaging system)
BrightView SPECT
Product Code: 882480
BrightView X
Product Code: 882478
BrightView XCT
Product Code: 882482
ARTG Numbers: 117642 and 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
Several software issues were identified which will be corrected with the release of a new software version.
1. When positioning for a relative 180 degree non-circular acquisition, if the second (bottom) detector is not positioned correctly, it may result in an inappropriate rotation orbit calculation for the patient being imaged. This may result in the detectors coming in contact with the patient.
2. As the gantry system moves to a relative 90 degree scan position of the detectors, a patient/operator may move their hands or arms into the path of the detectors, resulting in contact with the patient/operator.
3. When a user manually positions the patient for an exam and is translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet which may result in a pinch point or table tilt if not engaged with the catcher. This problem can only occur on the BrightView X or the BrightView XCT system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising users to always follow the Instruction For Use (IFU), and is providing additional instructions to prevent the issues from occurring. A software upgrade will be installed on all affected systems as a permanent correction for the issues.
This action has been closed out on 22/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |