System, Imaging, Pulsed Doppler, Ultrasonic
Radiology · 21 CFR 892.1550
Recent MDR events
2,659 adverse event reports on file
- Sparq Ultrasound SystemJul 27, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100280
- EPIQ 5Jul 27, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100281
- EPIQ 5Jul 22, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100279
- AFFINITI CVX ULTRASOUND SYSTEMJul 21, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100278
- VIEWMATE¿ Z ULTRASOUND CONSOLE WBATTERY ZS3Jul 21, 2026MalfunctionAbbott Medical2184149-2026-00205
- SIUI APOGEE 2300 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEMJul 20, 2026InjuryShantou Institute Of Ultrasonic Instruments Co.,lt3017944270-2026-00004
- CX50Jul 17, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100277
- EPIQ CVXJul 16, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100276
- KOSMOSJul 15, 2026MalfunctionEchonous, Inc.3013757696-2026-00001
- EPIQ 5Jul 14, 2026MalfunctionPhilips Ultrasound, Inc3019216-2026-100275
Event type breakdown
Recalls
298 recall events for this product code
- Philips Ultrasound, LLCCompletedDec 31, 2025
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Z-1007-2026 · View FDA record ↗ - Philips Ultrasound, LLCOpen, ClassifiedDec 4, 2025
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Z-0883-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, F
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0435-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0436-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0437-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0438-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0439-2026 · View FDA record ↗ - B-K Medical A/SOpen, ClassifiedNov 6, 2025
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
Z-0440-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedOct 15, 2025
LOGIQ P10 series with software version R4.5.7 Model Number
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Z-0155-2026 · View FDA record ↗ - GE Medical Systems, LLCOpen, ClassifiedOct 15, 2025
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Z-0156-2026 · View FDA record ↗
Registered firms
2,767 firms currently registered for this product code
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
Canon Inc.
OHTA-KU Tokyo, JP
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Hukui Biotechnology Co., Ltd.
Zhubei City Hsinchu, TW
Philips Ultrasound Llc
BOTHELL, WA, US
Sonoscape Medical Corp.
SHENZHEN Guangdong, CN
Wipro Ge Healthcare Private Ltd.
Bangalore Karnataka, IN
Siemens Healthcare S.r.o.
Kosice-Barca Kosicky, SK
Ge Medical Systems, Israel Ltd.
Haifa, IL
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
510(k) clearances
1,181 clearances for this product code
- GE Medical Systems Ultrasound and Primary care Diagnostics, LLCAug 7, 2026
K261668 · Venue Go
- Philips Ultrasound, LLCAug 4, 2026
K262311 · Alturion Series Diagnostic Ultrasound System
- GE Medical Systems Ultrasound and Primary Care DiagnosticsJul 30, 2026
K261835 · LOGIQ Focus
- IMGFAX CO., LTD.Jul 30, 2026
K261288 · Handheld Ultrasound Scanner
- Samsung Medison Co., Ltd.Jul 28, 2026
K261412 · V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;
- Philips Ultrasound, LLCJul 27, 2026
K261211 · Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
- Beijing Konted Medical Technology Co.,LtdJul 23, 2026
K261081 · Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
- Esonic Technology (Wuhan) Co., Ltd.Jul 23, 2026
K261272 · ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system