Agency classClass IIOur severity:High FDA (Devices)·Z-1102-2013·Announced 2013-04-24

Philips IntelliSpace Portal Software Recall for URL PACS Integration Issue

Philips is recalling IntelliSpace Portal software version 4.0.2 due to a display error when using URL PACS integration. The issue causes the Review monitor to display incorrect patient studies.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential for clinicians to review incorrect patient images, which is a risk-of-harm product issue where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc. is recalling 313 units of IntelliSpace Portal (ISP) software, specifically version 4.0.2, due to a defect in the URL PACS integration configuration. The IntelliSpace Portal is a multimodality thin-client applications server that delivers diagnostic viewing and clinical applications to healthcare enterprises.

The recall was initiated after Philips was notified that when loading a study to an analysis application using the URL PACS integration, the Review monitor may fail to update correctly. Specifically, if another study is opened by a review application, the Analysis monitor updates with the current patient's study, but the Review monitor continues to display the previous study. This discrepancy could lead to the review of incorrect patient data.

The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. Healthcare facilities using this specific software version with URL PACS integration should verify their configuration and contact Philips for corrective action.

The recalled product

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…
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Medical Software
Hazard: incorrect-data-display
Affected units: 313

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model #881001
Serial #s: 79916
79932
79933
79935
79936
79937
79939
79940
79943
80071
80914
80916
80925
80926
80928
80932
80939
80963
80965

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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