Transducer, Ultrasonic, Diagnostic
Radiology · 21 CFR 892.1570
Recent MDR events
3,948 adverse event reports on file
- CooperSurgicalJul 30, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00079
- CooperSurgicalJul 30, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00080
- CooperSurgicalJul 30, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00077
- CooperSurgicalJul 30, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00081
- CooperSurgicalJul 30, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00078
- SiteRiteJul 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05311
- SiteRite CUEJul 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05278
- SiteRite CUEJul 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05281
- CooperSurgicalJul 29, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00073
- CooperSurgicalJul 29, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00074
Event type breakdown
Recalls
147 recall events for this product code
- Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1618-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1619-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1620-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1621-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1622-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1623-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips OMNI III TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1624-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1625-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1626-2026 · View FDA record ↗ - Philips Ultrasound, IncOpen, ClassifiedMar 24, 2026
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Z-1627-2026 · View FDA record ↗
Registered firms
3,347 firms currently registered for this product code
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
Parallel Design Sas
VALBONNE, FR
Wipro Ge Medical Device Manufacturing Private Limited
Bangalore Karnataka, IN
Fujifilm Healthcare Manufacturing Corporation Sano Office
Sano City Tochigi, JP
Samsung Medison Co., Ltd.
HONGCHEON-GUN Gangwon, KR
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Hukui Biotechnology Co., Ltd.
Zhubei City Hsinchu, TW
Philips Ultrasound Llc
BOTHELL, WA, US
Sonoscape Medical Corp.
SHENZHEN Guangdong, CN
Sterigenics U.s., Llc
Corona, CA, US
Echosens Creteil
Creteil Val-de-Marne, FR
Hologic, Inc.
Marlborough, MA, US
Sheathing Technologies, Inc.
MORGAN HILL, CA, US
Hebei Mita Biotechnology Limited
Hong Kong, HK
Wipro Ge Healthcare Private Ltd.
Bangalore Karnataka, IN
Siemens Healthcare S.r.o.
Kosice-Barca Kosicky, SK
Ge Medical Systems, Israel Ltd.
Haifa, IL
510(k) clearances
412 clearances for this product code
- UC-CARE , Ltd.Jul 30, 2026
K260161 · SmartGuide Disposable Guides and Grids
- Accurate Access, LLCJul 27, 2026
K262474 · ND Needle Guidance System
- Rivanna Medical, Inc.Jul 24, 2026
K261014 · Accuro® 3S Needle Guide Kit
- Olympus Medical Systems CorporationSep 18, 2025
K250883 · ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
- Olympus Medical Systems CorporationJul 11, 2025
K250762 · ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
- Mendaera, Inc.Jul 2, 2025
K250524 · Mendaera Guidance System
- Rivanna Medical, Inc.Jun 13, 2025
K250469 · Accuro® 3S Needle Guide Kit
- Vitrolife Sweden ABAug 30, 2024
K241662 · Ultrasound Transducer Cover