Xper Information Management System 5Recalls & reported problems
Philips Medical Systems Nederland B.V. · The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838100084), received between Oct 31, 2024 and Sep 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Application Program Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- May 2, 2024Open, Classified
Potential for pressure wave data synchronization from two devices may not be correct.
Z-1926-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Application Program Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the name of a signed user was not listed during the finalization of a report. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this constitutes a reportable malfunction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50660862 ↗MalfunctionOct 31, 2024Application Program Problem; Application Program Problem
IT WAS REPORTED TO PHILIPS THAT THE XPER INFORMATION MANAGEMENT SYSTEM (XPERIM) SOFTWARE WAS NOT ABLE TO LAUNCH WHILE A PATIENT WAS BEING PREPPED FOR A PROCEDURE. IT WAS CONFIRMED THERE WAS NO PATIENT HARM. THE INVESTIGATION INDICATED THAT THE PROBLEM OCCURRED WHILE THE STAFF WAS PREPPING THE PATIENT. THE STAFF ATTEMPTED TO START UP XPERIM AND IT FAILED TO LAUNCH. BASED ON THE RESULTS OF THE ANALYSIS, THE CAUSE OF THE REPORTED PROBLEM WAS THAT THE DATACENTER WAS OUT OF MEMORY, THEREFORE XPERIM WAS UNABLE TO REACH OUT AND START THE COMMUNICATION WITH THE DATACENTER. THIS CAUSED XPERIM TO BECOME UNRESPONSIVE AND IT FAILED TO START. PERFORMING A RESTART OF THE DATACENTER APPLICATION RESTORED FUNCTIONALITY AND RESOLVED THE ISSUE. PHILIPS PERFORMED AN ASSESSMENT AND FOUND THE REPORTED ISSUE COULD NOT LEAD TO DEATH OR SERIOUS INJURY SHOULD IT RECUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579390 ↗
Other Computer, diagnostic, programmable devices
- ZIO AT Patch A100A100XIrhythm Technologies, Inc. · Computer, Diagnostic, Programmable1 recall14 deaths629 reports
- CARTO 3 FG540000Biosense Webster (Israel) Ltd. · Computer, diagnostic, programmable1 death437 reports
- Sensis 10764561Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE5 recalls8 reports
- Sensis Vibe Hemo 11007641Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE4 recalls1 death22 reports
- Sensis Vibe Combo 11007642Siemens Healthcare GmbH · COMPUTER, DIAGNOSTIC, PROGRAMMABLE4 recalls1 death6 reports
- Change Healthcare Cardiology Hemo 15.1Change Healthcare Canada Company · Computer, Diagnostic, Programmable4 recalls1 report
- Change Healthcare Cardiology Hemo 15.0.1Change Healthcare Canada Company · Computer, Diagnostic, Programmable3 recalls1 death1 report
- Change Healthcare Cardiology Hemo 14.3.2Change Healthcare Canada Company · Computer, Diagnostic, Programmable3 recalls0 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page