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AFFIRM™ CONTRAST BIOPSY
Hologic, Inc. · Model AFFIRM™ CONTRAST BIOPSY SOFTWARE · UDI-DI 15420045512948
IZH
Prescription
1
510(k) clearances
443
Adverse events
14
Recalls
26
Facilities
Description
Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.
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 could result in patient |
| 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 specific angulated view |
| 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 specific angulated view |
| 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 impact patient safet |
| 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 technical specificatio |
| 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 technical specificatio |
| 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 technical specificatio |
| 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 technical specificatio |
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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.