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Varex Imaging Nederland B.V. · Model SolidStateMC 601 · UDI-DI 08718755004151
10
510(k) clearances
160
Adverse events (8 deaths)
4
Recalls
43
Facilities
Description
The SolidStateMC is a AEC-sensor (AEC=Automatic Exposure Control)
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.