| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00074-1 |
| Product Name/Description |
BrightView systems – BrightView, BrightView X and BrightView XCT
BrightView
Model Number: 882480
12 Digit Format: 453560279781, 453560279791, 453560279811, 453560279801
4 x 4 Digit Format: 2170-3000A, 2170-3001A, 2170-3002A, 2170-3003A
BrightView X
Model number: 882478
12 Digit Format: 453560824741, 453560829261
BrightView XCT
Model number: 882482
12 Digit Format: 453560462131, 453560749161
ARTG: 117642 - Cancelled as of 18/12/2023
ARTG: 117440 - Cancelled as of 18/12/2023 |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
A detector support component may fail due to unexpected wear.
• Scenario 1: If the detector is below the center of the gantry bore and the detector support component fails, the detector may descend downward unexpectedly and potentially contact the patient. There is a potential for abrasion, contusion, laceration, and/or fracture to the patient’s lower limb(s). Additionally, there will be an interruption to normal system operation. A rescan or re-injection of radiopharmaceutical to the patient may be required.
• Scenario 2: If the detector is above the center of the gantry bore and the detector support component fails, the detector will not be able to move to complete the imaging. A rescan or re-injection of radiopharmaceutical to the patient may be required.
Philips has received a complaint associated with this issue; however, there are no reports of injury or serious harm. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will conduct an inspection and correction if necessary to resolve the issue on the affected systems. In the interim, users should refer to the workaround outlined in the Customer Letter (supplied to impacted facilities by Philips) |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |