| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00384-1 |
| Product Name/Description |
AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0
(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras)
ARTG Number: 117441 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90° or 180° relative to one another. However, certain gamma cameras, e.g., the Marconi Axis and Irix cameras, permit acquisitions at other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro, and the results will likely be erroneous.
Incorrect computational results may lead, under certain circumstances to misdiagnosis, e.g., an incorrect assessment of a patient’s myocardial perfusion, in which case, the patient may not receive further indicated diagnostic tests or therapy, putting the patient at risk of a subsequent cardiovascular event.
Philips has not received any report of any patient harm associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to follow instructions in the customer letter to determine whether the system is affected. If it is affected, users are asked NOT to use the AutoSPECT Pro application on the affected data sets until Philips modifies its software to prevent it from reconstructing data acquired using these modes. Instead, use the reconstruction applications on the camera’s native processing computers (e.g. Odyssey). Philips is recommending a review of previously processed data based on the clinical context. This action has been closed-out on 27/01/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |