Philips IntelliSite Pathology Solution 3.xRecalls & reported problems
Philips Medical Systems Nederland B.V. · Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838085640), received between May 9, 2019 and May 9, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2019Incorrect, Inadequate or Imprecise Result or Readings
AT THE UNIVERSITY OF (B)(6) WE ARE IN THE PROCESS OF ADOPTING WHOLE SLIDE SCANNING USING THE FDA APPROVED PHILIPS PLATFORM (PHILIPS INTELLIPATH SYSTEM) FOR PRIMARY SIGN-OUT IN PATHOLOGY. OUR GOAL IS TO GO FULLY DIGITAL BY THE END OF 2019. THE SCANNING FACILITY WITH SUFFICIENT NUMBER OF SCANNERS, THE NETWORK, AND STORAGE ARE ALL IN PLACE. WE ESTABLISHED SEVERAL WORKING GROUPS WITH FACULTY, TRAINEES, AND STAFF TO ASSIST THE TRANSITION. VALIDATION FOR SUBSPECIALTY SIGN OUT IS ONGOING AND 4 SERVICES (KIDNEY, LUNG, BONE AND SOFT TISSUE, HEART) ARE ALREADY ON A FULLY DIGITAL PLATFORM. AS PART OF THE SUBSPECIALTY VALIDATION FOR THE BREAST SERVICE WE NOTICED THAT THE SCANNING FIDELITY (I.E., CONGRUENCE BETWEEN GLASS SLIDE CONTENT AND DIGITAL IMAGE CONTENT) WAS SUBPAR IN A SIGNIFICANT PROPORTION OF MASTECTOMY CASES. THEREFORE, WE DECIDED TO CONDUCT A LARGER SCALE STUDY TO ADDRESS THE MAGNITUDE OF THIS ISSUE. IN BRIEF, DIGITAL IMAGES MISSED A SIGNIFICANT PROPORTION OF TISSUES PRESENT IN 38% OF THE GLASS SLIDES. WE INFORMED PHILIPS ABOUT THE FINDINGS AND SENT ALL THE TEST SLIDES (ALONG WITH DATA) TO (B)(6) TO CONFIRM. AS A POTENTIAL SOLUTION, WE RECOMMENDED PHILIPS TO CONSIDER CHANGING THE SC
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8596202 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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