Recall Z-1102-2013— Philips Medical Systems (Cleveland) Inc

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-02-12, terminated 2013-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., 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. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.. Reason: Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration, after another study was opened by a review application, the Analysis monitor is updated with the study of the current patient, but the Review monitor conti.

Recalling firm

Philips Medical Systems (Cleveland) Inc

Classification

Class II

Status

Terminated

Initiated

2013-02-12

Terminated

2013-11-04

Firm location

Cleveland, OH, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.