Flourocsan InSight InSight FDRecalls & reported problems
Hologic, Inc. · The Fluoroscan InSight FD System is a mini C-Arm fluoroscopic imaging system designed to provide physicians with general fluoroscopic visualization of a patient, including, but not limited to, surgical orthopedic and podiatry use, critical and emergency care procedures, and light anatomy imaging situations. · 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 15420045505773), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Poor Quality Image” (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
- Poor Quality Image1
Patient problems
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2017Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THEY WERE GETTING GRAINY AND WASHED OUT IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THEY NEEDED AN THE X-RAY SOURCE REPLACED. ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.
Patient problems: Not Applicable
MAUDE report 7086232 ↗
Other Image-intensified fluoroscopic x-ray system, mobile devices
- O-ARM® BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile2 recalls2,132 reports
- O-ARM® BI70000028120Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile1,343 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile2 recalls1 death811 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile259 reports
- Zenition Zenition 70Philips Medical Systems Nederland B.V. · Image-Intensified Fluoroscopic X-Ray System, Mobile2 recalls80 reports
- O-armTM O2 Imaging System BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile2 recalls1 death72 reports
- Zenition Zenition 50Philips Medical Systems Nederland B.V. · Image-Intensified Fluoroscopic X-Ray System, Mobile3 recalls21 reports
- O-ARM® BI70002000Medtronic Navigation, Inc. · Image-intensified fluoroscopic x-ray system, mobile2 recalls65 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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