| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00051-1 |
| Product Name/Description |
BrightView X/XCT/XCT Upgrade
882480: BrightView (version 1.2.3 or 1.2.4)
882478: BrightView X (version 2.5.3 or 2.5.4)
882482: BrightView XCT (version 2.5.3 or 2.5.4)
882454: BrightView XCT Upgrade (version 2.5.3 or 2.5.4)
ARTG Numbers: 117642 and 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified 4 issues with the BrightView systems:
1. During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Although unlikely, if the collision sensors malfunction & the operator fails to activate the E-stop, this could lead to serious bodily injury for the patient.
2. During a scan, the gantry motion may halt prematurely. This causes the scan sequence to pause.
3. Operator will receive a warning message that the scan may not complete & re-mark the points used to define the orbit when defined with a Detector Relative Angle of 90 & Head first supine/feet first prone setting.
4. Resolved Defects section of User Release Document 1.2.4/2.5.4 for BrightView, BrightView X & XCT listed 2 Pre-Programmed Motions (PPMs) whose motion sequences were changed by the release of s/w v1.2.4/ 2.5.4 |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor will provide a system software upgrade to correct the reported issues.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |