Omega Medical Imaging CS50Recalls & reported problems
Omega Medical Imaging, LLC · CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4. · Class 2
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 00853901007001), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.
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
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.
MalfunctionSep 18, 2024
FLUOROSCOPY ERCP BILIARY ORDER DID NOT TRANSFER TO OMEGA WORKLIST AFTER PRESSING THE QUERY BUTTON. SAMSUNG IPAD WOULD NOT CONNECT TO WI-FI AND SMALL MONITOR ON THE RIGHT TO THE 2 COMPUTERS WOULD NOT TURN ON. ATTEMPTED TO SHUT DOWN AND TURN SYSTEM DOWN MULTIPLE TIMES BUT THE SAME ISSUES AS STATED ABOVE STILL HAPPENED. MANUALLY PUT PT'S NAME, DOB, AND MR NUMBER. MD TESTED FLUORO AND IT WORKED BUT UNABLE TO SAVE PICTURES AND NO ACCESSION NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245808 ↗
Other Solid State X-Ray Imager (Flat Panel/Digital Imager) devices
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- SEDECAL SM-40HF-B-D-VIRSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)12 recalls1 report
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- DigitalDiagnost C90 712034Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)3 recalls90 reports
- DigitalDiagnost C90 712035Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)4 recalls17 reports
- DigitalDiagnost 712031Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls65 reports
- NA GM85Samsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls4 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 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
- 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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