| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01105-1 |
| Product Name/Description |
PHILIPS MX 16-slice CT System, software: v1.1.3.1167; v1.1.4.21425; v1.1.4.21424; v1.1.4.21422
ARTG number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
The orientation of images is displayed incorrectly. When operator chooses “gantry on the right side” from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. This issue may result in potential misdiagnosis or incorrect anatomy classification leading to unnecessary treatment/procedure. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing temporary work around instructions in the customer letter until updated software in a Service Pack is installed in the affected systems. The Service Pack will also correct the following other issues:
- When a surview which is longer than 557mm is stopped by using “Abort” function during the scan process, the position of scan box in surview image is not correct.
- For dental applications, when a patient scan is taken with Gantry tilted, and the tilt angle falls in the range from 1 to -1 degree (not including 0 degree position), the data post-processing may not operate normally and the images may not be displayed.
- If the user stops a surview using the “Abort” function during the second part of the scan, the positions of the scan box are not consistent. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |