| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00747-1 |
| Product Name/Description |
MX8000 IDT 16 Slice CT Scanner
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The CT system phantom supplied with the affected scanners has a special pin by which the customer can check the Low Contrast (LC) detectability for quality assurance. This pin consists of a Nylon (Aculon) body with six smaller Lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from Aculon.
The LC test is performed by visually inspecting the section and selecting the smallest detectable Lexan pin for a predefined scan protocol as defined in the Instructions For Use (IFU) manual. This manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable.
This pin visibility deteriorates over time because of slow water absorption. As the pin visibility deteriorates, the test becomes unreliable and inaccurate. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The customer letter is providing a guideline to a more reliable check of the image noise on the water layer of the system phantom to assure that LC is within the specification. The letter is an addendum to the Instructions for Use. It replaces the Image Quality Low Contrast measurement instructions found in the Instructions for Use. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |