IntelliSpace Critical Care and Anesthesia IntelliSpace CC & Anesthesia JRecalls & reported problems
Philips Medical Systems Hsg · IntelliSpace Critical Care and Anesthesia · Class 2
All models of IntelliSpace Critical Care and Anesthesia (3)
Data updated Oct 18, 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 00884838113763), received between Apr 13, 2026 and Apr 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Data Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Data Problem
IT WAS REPORTED THAT ICCA LAB RESULTS HAD AN ISSUE REGARDING INBOUND INTERFACE INVOLVING THE HANDLING OF UPDATED SPECIMEN COLLECTION TIMESTAMPS SENT FROM THE LABORATORY INFORMATION SYSTEM (LIS). WHEN A BIOLOGIST MODIFIED THE SAMPLE DATE AND TIME (OBR 7), THE LIS GENERATED A NEW HL7 ORU^R01 MESSAGE USING THE SAME UNIQUE SPECIMEN IDENTIFIER (OBR 3.1) BUT WITH A CORRECTED TIMESTAMP IN OBR 7 OR OBX 14. ICCA DID NOT UPDATE THE PREVIOUSLY STORED SAMPLE DATE/TIME FOR THAT SPECIMEN; INSTEAD, IT UPDATED ONLY THE CHART TIME FIELD WHILE CONTINUING TO DISPLAY THE RESULT UNDER THE ORIGINAL CHART TIME COLUMN IN THE LAB FLOWSHEET. THIS BEHAVIOR PREVENTS THE RESULT FROM BEING REPOSITIONED ACCORDING TO THE CORRECTED TIMESTAMP AND MAY LEAD TO MISINTERPRETATION OF LABORATORY DATA TIMING, POSING A POTENTIAL PATIENT SAFETY RISK. HOWEVER, THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860704 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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