Home › Device types › MUE
Full Field Digital, System, X-Ray, Mammographic
FDA product code MUE · Class 2 · Radiology
244
Registered devices
670
Adverse events
41
Recalls
56
510(k) clearances
Devices with this code
2D biopsy compression plate — FUJIFILM CORPORATIONSelenia FFDM — Hologic, Inc.Selenia FFDM — Hologic, Inc.Compression plate for axilla radiography — FUJIFILM CORPORATIONSelenia FFDM — Hologic, Inc.Selenia Dimensions — Hologic, Inc.Selenia FFDM — Hologic, Inc.Selenia® Dimensions® — Hologic, Inc.Selenia Dimensions — Hologic, Inc.Selenia FFDM — Hologic, Inc.Needle holder E — FUJIFILM CORPORATIONSlide stopper C — FUJIFILM CORPORATIONI-View — Hologic, Inc.Face Guard T — FUJIFILM CORPORATIONMAMMOMAT B.brilliant — Siemens Healthcare GmbH24x30 Compression plate (Low) — FUJIFILM CORPORATIONBiopsy spacer — FUJIFILM CORPORATIONDIRECTVIEW CR Mammography Cassette with HR Screen — CARESTREAM HEALTH, INC.not applicable — GE MEDICAL SYSTEMSnot applicable — GE MEDICAL SYSTEMSCR-IR 392 — FUJIFILM CORPORATIONDIRECTVIEW CR Mammography Cassette with EHR-M Screen — CARESTREAM HEALTH, INC.Selenia® Dimensions® — Hologic, Inc.DIRECTVIEW CR Mammography Cassette with EHR-M Screen — CARESTREAM HEALTH, INC.
Recent 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 | 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 install |
| 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 install |
| 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 install |
| 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). |
| 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 rang |
| 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 th |
| 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 |
| 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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