Home › Device types › IZO
Generator, High-Voltage, X-Ray, Diagnostic
FDA product code IZO · Class 1 · Radiology
582
Registered devices
160
Adverse events
4
Recalls
163
510(k) clearances
Devices with this code
Varex Imaging — Varex Imaging CorporationSEDECAL — SEDECALVarex Imaging — Varex Imaging CorporationEDITOR HFe — Spellman High Voltage Electronics GmbHVarex Imaging — Varex Imaging CorporationS Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., LtdXS-100 Generator — Philips Medical Systems DMC GmbHEpsilon High Voltage Generator — EMD TechnologiesVarex Imaging — Varex Imaging Nederland B.V.SEDECAL — SEDECALDRGEM — DRGEM CorporationVarex Imaging — Varex Imaging CorporationQG-40-SE — CARESTREAM HEALTH, INC.EDITOR HFe — Spellman High Voltage Electronics GmbHiRay — iRay Imaging Technology (Haining) LimitedDRGEM — DRGEM CorporationQG-50 — CARESTREAM HEALTH, INC.Varex Imaging — Varex Imaging CorporationiRay — iRay Imaging Technology (Haining) LimitedSEDECAL — SEDECALDelta — DELTA ELECTRONICS, INC. CHUNGLI 5 PLANTVarex Imaging — Varex Imaging CorporationDRGEM — DRGEM CorporationVarex Imaging — Varex Imaging Corporation
Recent 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 |
| 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 simultan |
| 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 ge |
| 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 pat |
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