| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01100-1 |
| Product Name/Description |
Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1
ARTG number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips became aware through a customer complaint that while performing a CCT examination on an Ingenuity CT system, the first image was marked as “last shot” rather than the actual “last shot” acquired. After the clinician pressed the pedal for first exposure, images were displayed as the “last shot”. Subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labelled as the “last shot”. Eventually all images appeared. During an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have real-time feedback of needle placement when the needle is near vital structures (major blood vessel, organ, etc). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising that affected users should check their CCT exam card and correct if the issue exists as described in the instructions supplied with the customer letter. A Philips Field Service Engineer will contact customers to schedule the software update at their site to permanently correct the issue. This action has been closed-out on 05/09/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |