| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00616-1 |
| Product Name/Description |
MX 16-slice CT x-ray systems with software version v1.1.4.21426.
ARTG Number: 158775 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The following issues have been found in MX 16-slice systems.
1) During the filming operation, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient.
2) During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.
3) If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function.
There have been no reports of injuries. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 02/03/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |