NA
ECOTRON · Model Anyview-500DR · UDI-DI 08800019200277
1
510(k) clearances
10,986
Adverse events (8 deaths)
49
Recalls
68
Facilities
Description
1. Line Voltage: 220~230V, 50/60Hz 2. Output Power: 5.0kW 3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA 4. Radiography Mode - kV range: 40~125kV, mA range: 20~100mA, mAs range: 0.8~200mAs 5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU 6. Detector - VIVIX-D 1212G (VIEWORKS), 12 x 12 inch
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2021-06-10 | GE OEC Medical Systems, Inc | There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
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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.