Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/20/2014
Class lI:
PRODUCT
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Recall Number Z-2237-2014
REASON
The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (EF) may be different. Problem 2: When processing using one of the following NM clinical applications: AutoQUANT, Emory Cardiac Toolbox, Corridor4DM, or NeuroQ, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory. Problem 3: While using the NM Viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out. Problem 4: While displaying PET images within CT Viewer, the SUV results displayed may be calculated with an SUV method different from the one specified in system preferences. This issue affects the CT Viewer and Multi-Modality Tumor Tracking applications. The expected behavior in such a case is that the application displays a warning that SUV cannot be calculated due to missing information, and the images are displayed with the original acquisition units (BQ/ML). Instead, in affected systems, if the patient height has not been entered and the selected SUV calculation method requires height data (i.e., SUV-BSA), the system may display an SUV calculated using a different method (SUV-BW) without providing any warning that required data had not been entered or informing the user of the change.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Andover, MA on 4/27/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1099 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
