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Senographe Pristina
GE MEDICAL SYSTEMS · Model EKB6 · UDI-DI 00195278276971
1
510(k) clearances
670
Adverse events (5 deaths)
43
Recalls
43
Facilities
Description
Senographe Pristina Core System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-28 | GE Medical Systems, LLC | GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of th |
| 2026-08-28 | GE Medical Systems, LLC | GE HealthCare has become aware of a nonconformance to certain Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of th |
| 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 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 |
| 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 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. |
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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.