iCT iCT SystemRecalls & reported problems
IMRIS Imaging, Inc. · iCT System 115219-000 · Class 2
- 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 00857534006219), received between Oct 21, 2022 and Oct 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Device Slipped1
- Mechanical Jam1
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.
MalfunctionOct 21, 2022Device Slipped; Device Dislodged or Dislocated; Mechanical Jam; Device Slipped; Device Dislodged or Dislocated; Mechanical Jam
DURING A RESEARCH, ANIMAL STUDY CASE, THE ICT CABLE CARRIER LINKAGES WERE DISCOVERED TO HAVE SLIPPED OFF OF THE OVERHEAD SUPPORT TRAY AND REMAINED SUSPENDED. THIS WAS OBSERVED BY THE USER FACILITY STAFF IN BETWEEN STUDY CASE SCANS AND WAS REPORTED TO OCCUR DURING NORMAL SYSTEM MOVEMENT. SCANNING WAS REPORTEDLY NOT INTERRUPTED AND NO REPEAT SCANNING WAS REQUIRED. THE USER FACILITY STAFF LIFTED THE CABLE CARRIER LINKAGES BACK ONTO THE SUPPORT TRAY AND COMPLETED THE ANIMAL STUDY CASE; A DELAY OF 30 MINUTES WAS INCURRED DURING THIS TIME. AFTER CASE COMPLETION THE CT SYSTEM WAS ABLE TO BE MOVED BACK TO THE HOME POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15655505 ↗
Other System, X-Ray, Tomography, Computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.