Radiology · PMA · 2024
MAMMOMAT B.brilliant with Tomosynthesis Option
SIEMENS MEDICAL SOLUTIONS USA, INC.. Approved by FDA on 23 September 2024 under submission P140011/S008, product code OTE (digital breast tomosynthesis). What FDA's record says, in FDA's words.
Device record · P140011/S008
- Device. MAMMOMAT B.brilliant with Tomosynthesis OptionDEVICE
- Company. SIEMENS MEDICAL SOLUTIONS USA, INC.COMPANY
- Decision. 23 September 2024, PMADECISION
- Panel. RadiologyPANEL
- Product code. OTE, Digital Breast TomosynthesisCODE
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,032 reports filed against devices carrying product code OTE. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Selenia Dimensions Mammography Systems, 3D · Hologic, Inc · report 3005496266-2026-00291
It was reported that a mammography system produced a loud noise described as "like a spark" during an exposure, followed by an electrical/burning smell. There were no reported clinical consequences associated with this event. Service evaluation identified a failed x-ray tube, generator assembly and vertical travel (VTA) drive board. The field engineer indicated that the x-ray tube appeared to have arced, resulting in damage to the generator assembly and VTA drive board. The system was also […]
30 September 2026 · Malfunction · 3Dimensions · Hologic, Inc · report 3005496266-2026-00292
It was reported that a Dimensions system displayed an error related to high voltage arc detected, during a quality control testing. The system remained nonoperational following a reboot. No patient or user impact was reported. During service evaluation, the field service engineer identified arcing of the high voltage cable inside the generator and found the cable to be burnt. The high-voltage cable was replaced. An unpleasant odor for the generator during operation was also reported. the x-ray […]
30 September 2026 · Malfunction · 3Dimensions · Hologic, Inc. · report 3005496266-2026-00293
28 September 2026 · Malfunction · 3Dimensions · Hologic, Inc. · report 3005496266-2026-00285
Customer reported an incident involving a mammography system with a burning smell and smoke coming from the system while it was powered on, with GEN error codes 25:30 and 25:56 displayed. The incident did not occur during an examination, and no patient was present. Facility staff were present; however, no smoke inhalation, injury, or further impact was reported.Manufacturer Field Service Engineer (FSE) visited the site and evaluated the reported burning smell and error codes. The issue was […]
28 September 2026 · Malfunction · 3Dimensions · Hologic, Inc. · report 3005496266-2026-00286
Manufacturer's Field Service Engineer (FSE) identified an issue with mammography system during a field inspection. While inspecting the Vertical Travel Assembly (VTA), three loose bolts were identified within the VTA assembly. No uncommanded movement or vibration of the C-Arm was reported. No injury to the patient or staff was reported.FSE confirmed that the VTA bolts were loose. No bolts were found to be damaged, missing, or sheared. The bolts were re-tightened to the correct torque according […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OTE, in Radiology, from SIEMENS MEDICAL SOLUTIONS USA, INC., or approved in 2024. The whole record is at FDA AI-enabled medical devices.
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