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Flourocsan InSight
Hologic, Inc. · Model InSight FD Refresh · UDI-DI 15420045509634
OXO
Prescription
10
510(k) clearances
10,999
Adverse events (8 deaths)
50
Recalls
69
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-03 | ZIEHM-ORTHOSCAN INC | The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart. |
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2024-11-21 | GE OEC Medical Systems, Inc | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.