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AWS-h
FUJIFILM CORPORATION · Model FDR-3000AWS · UDI-DI 04547410316902
MUE
Prescription
1
510(k) clearances
659
Adverse events (5 deaths)
41
Recalls
42
Facilities
Description
FDR-3000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-08 | Hologic, Inc | Complaints have been received of systems developing loose, missing, or broken internal bolts over time. |
| 2025-10-24 | GE Medical Systems, LLC | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). |
| 2025-10-24 | Siemens Medical Solutions USA, Inc | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was des |
| 2025-10-24 | Siemens Medical Solutions USA, Inc | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was des |
| 2025-10-24 | Siemens Medical Solutions USA, Inc | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was des |
| 2023-12-26 | GE Medical Systems, SCS | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. |
| 2020-05-07 | Siemens Medical Solutions USA, Inc | If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from |
| 2020-01-21 | Hologic, Inc. | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. |
| 2019-07-23 | Siemens Medical Solutions USA, Inc | An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare |
| 2019-05-16 | GE Healthcare, LLC | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. |
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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.