| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00409-1 |
| Product Name/Description |
Philips Incisive CT & CT 3500 System
Model numbers: 728143, 728144, 728148, 728149 and 728134
Multiple serial numbers
ARTG 229637
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
ARTG 352131
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/05/2023 |
| Responsible Entity |
|
| Reason/Issue |
An issue with the Precise Position option may result in incorrect image orientation (i.e., flipped or reversed images). The Precise Position option uses automatic camera detection for patient orientation. This automatic detection function will overwrite the pre-set patient orientation defined in the scan protocol. If the auto-detected patient orientation is incorrect and is unnoticed by the operator prior to scanning, the images may be flipped or reversed.
As of March 2023, Philips has received one reported adverse event associated with this issue. There was no harm to the patient, however the patient was initially misdiagnosed due to incorrect image orientation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised that a Philips Field Service Engineer will install a software upgrade to address the issue. The software upgrade will be available in Q3 of 2023, with a planned completion timeframe of 6 months.
In the interim, customers are advised to follow the work around instructions in the customer letter (supplied to impacted facilities by the sponsor) as follows:
- Refer to the IFU for the Incisive CT / CT 3500 system to ensure proper use of the Precise Position function (IFU Section 4.9).
- If the patient orientation automatically selected by Precise Position is inconsistent with the pre-set protocol, please correct the settings by:
· Manually select the correct orientation in the Select Patient Orientation area in the New Patient interface, or
· Open the Select Patient Orientation list by clicking the patient orientation icon in the left upper corner of the series list and select the correct orientation.
This action has been closed out on 26/07/2024 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |