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Sign in to claim this brandPhilips Healthcare Informatics, Inc.
United States·US-MF-000002160
Last updated May 30, 2026
Information
- Country
- United States
- Address
- 4430, Rosewood Drive, Pleasanton, United States
- Website
- n/a
- —
- —
- [email protected]
- Phone
- n/a
- PRRC Contact
- Kenneth Revennaugh
- EUDAMED SRN
- US-MF-000002160
- FDA FEI Number
- —
- DUNS Number
- 095471327
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IntelliSpace PACS | IntelliSpace PACS - 4 | FDA UDI | Class II | Active |
| Intellispace Pacs 4.x | K111804 | FDA 510(k) | Class II | Active |
| IntelliSpace Clinical Applications | 837509 | EUDAMEDFDA UDI | Class IIa | Active |
| IntelliSpace Radiology | 836344 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 19, 2019 | Z-2338-2020 | — | completed | Images may potentially become corrupt while using the system. |
| Jul 24, 2014 | Z-2252-2014 | — | terminated | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data. |
| May 5, 2014 | Z-1646-2014 | — | terminated | When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed |
| Oct 14, 2013 | Z-0269-2014 | — | terminated | Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation. |
| Dec 29, 2008 | Z-0948-2009 | — | terminated | Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report. |
| Aug 29, 2008 | Z-0118-2009 | — | terminated | Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot |
| Jul 3, 2008 | Z-2346-2008 | — | terminated | Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances. |
| Jan 29, 2008 | Z-1443-2008 | — | terminated | When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. |
| Jan 29, 2008 | Z-1444-2008 | — | terminated | When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. |
| Jan 4, 2008 | Z-1141-2008 | — | terminated | Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor. |