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
SEDECAL — SEDECALEDITOR HFe — Spellman High Voltage Electronics GmbHQG-TV-IP-FM — CARESTREAM HEALTH, INC.Varex Imaging — Varex Imaging CorporationVarex Imaging — Varex Imaging Nederland B.V.EDITOR HFe — Spellman High Voltage Electronics GmbHSEDECAL — SEDECALSEDECAL — SEDECALS Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., LtdVarex Imaging — Varex Imaging CorporationSEDECAL — SEDECALSEDECAL — SEDECALVarex Imaging — Varex Imaging CorporationUD150B-40 — SHIMADZU CORPORATIONiRay — iRay Imaging Technology (Haining) LimitedDRGEM — DRGEM CorporationS Spellman High Voltage Electronics Corporation — Spellman High Voltage Electronics(Suzhou Industrial Park) Co., LtdCARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC.CMP 200 DR — Communications & Power Industries Canada IncEDITOR HFe — Spellman High Voltage Electronics GmbHSEDECAL — SEDECALCerteray iX — Philips Medical Systems DMC GmbHVarex Imaging — Varex Imaging CorporationQG-32-2 — CARESTREAM HEALTH, INC.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.