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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00385-1
Product Name/Description AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0

ARTG Number: 119929
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/04/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue AutoSPECT Pro is an application residing on Intellispace Portal workstation used to process, analyse, and display medical images/data obtained from other devices, including gamma cameras, which may be used in diagnosis.

The application was designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90° or 180° relative to one another. However, certain gamma cameras (Marconi Axis and Irix), permit acquisitions at other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro.

Although unlikely, there is potential that reliance on these results could lead to 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 such as myocardial infarction.

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 these 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.
Contact Information 1800 251 400 - Philips Customer Care Centre.