N/A
ECOTRON · Model SXG-80R · UDI-DI 08800019200161
10
510(k) clearances
160
Adverse events (8 deaths)
4
Recalls
43
Facilities
Description
LINE POWER RATING: 400V3~, 50/60Hz OUTPUT RATING: 82kW(1000mA@82kV, 800mA@102kV, 500mA@150kV) KVP range: 40~150kVp mA range: 10~1000mA mAs Range: 0.1~500mAs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-20 | Shimadzu Medical Systems | Shimadzu Medical Systems is recalling the Shimadzu X-ray High Voltage Generator due to the possibility of oil leaking from the x-ray tube housing under certain conditions. |
| 2011-01-17 | Philips Healthcare Inc. | Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously. |
| 2010-06-14 | Mallinckrodt Inc | Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lea |
| 2007-03-09 | GE Healthcare | GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has |
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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.