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.
What this means for you
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
- Hazard
- 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
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