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FDR-2000BPY
FUJIFILM CORPORATION · Model POSITIONER KIT BPSY HA USA E · UDI-DI 04547410327342
2
510(k) clearances
443
Adverse events
14
Recalls
26
Facilities
Description
The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates.
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.