Home › Device types › IZH
System, X-Ray, Mammographic
FDA product code IZH · Class 2 · Radiology
69
Registered devices
458
Adverse events
14
Recalls
176
510(k) clearances
Devices with this code
Affirm® — Hologic, Inc.Planmed — Planmed OyMAMORAY HD — AGFAMAMORAY HD S — AGFAMulticare Platinum — Hologic, Inc.AFFIRM™ CONTRAST BIOPSY — Hologic, Inc.MAMORAY HD — AGFAAffirm Prone Biopsy System — Hologic, Inc.BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRLBD PrecisionGlide — BECTON, DICKINSON AND COMPANYAffirm Prone Biopsy System — Hologic, Inc.MammoPad Radiolucent Cushion — Hologic, Inc.GIOTTO IMAGE — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRLAffirm Breast Biopsy Guidance System — Hologic, Inc.Affirm Prone Biopsy System — Hologic, Inc.Affirm Lateral Arm Upright Biopsy Accessory — Hologic, Inc.FDR-2000BPY — FUJIFILM CORPORATIONMammoPad Radiolucent Cushion — Hologic, Inc.Affirm Prone Biopsy System — Hologic, Inc.Affirm Prone Biopsy System — Hologic, Inc.BD PrecisionGlide — BECTON, DICKINSON AND COMPANYBD PrecisionGlide — BECTON, DICKINSON AND COMPANYSMART FINDER — IMS GIOTTO SPAAffirm Prone Biopsy System — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-05-13 | Hologic, Inc. | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which coul |
| 2012-07-02 | Beekley Corporation | Imaging artifact can occur on mammogram result |
| 2008-07-01 | GE Healthcare | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a spe |
| 2008-07-01 | GE Healthcare | GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a spe |
| 2005-11-16 | General Electric Med Systems LLC | GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may |
| 2004-07-09 | Fischer Imaging Corporation | X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning. |
| 2004-02-06 | General Electric Med Systems | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the te |
| 2004-02-06 | General Electric Med Systems | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the te |
| 2004-02-06 | General Electric Med Systems | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the te |
| 2004-02-06 | General Electric Med Systems | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the te |
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