System, Imaging, Pulsed Echo, Ultrasonic
Radiology · 21 CFR 892.1560
Recent MDR events
6,516 adverse event reports on file
- BD SiteRite 9 Ultrasound SystemJul 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05283
- Site-Rite 8Jul 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05342
- BD PREVUEJul 27, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05196
- SITE~RITE 8Jul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05132
- SITE~RITE 8 ULTRASOUND SYSTEMJul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05147
- SITE-RITE 8 SCANNERJul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05150
- SITE~RITE 8 ULTRASOUND SYSTEMJul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05151
- BD PREVUEJul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05140
- BD SITERITE 9 ULTRASOUND SYSTEMJul 20, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05112
- SITE-RITE 8Jul 20, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05116
Event type breakdown
Recalls
82 recall events for this product code
- Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1731-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1732-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1733-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1734-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1735-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1736-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1737-2026 · View FDA record ↗ - Civco Medical Instruments Co. Inc.Open, ClassifiedApr 1, 2026
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Z-1738-2026 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedJan 24, 2022
GE Vscan Extend, being sold as "Vscan Extend Console"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Z-0518-2022 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedJan 24, 2022
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Z-0519-2022 · View FDA record ↗
Registered firms
3,121 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
Echosens Creteil
Creteil Val-de-Marne, FR
Hologic, Inc.
Marlborough, MA, US
Wipro Ge Healthcare Private Ltd.
Bangalore Karnataka, IN
Siemens Healthcare S.r.o.
Kosice-Barca Kosicky, SK
Ge Medical Systems, Israel Ltd.
Haifa, IL
Nidek Incorporated
The Colony, TX, US
510(k) clearances
894 clearances for this product code
- Rivanna Medical, Inc.Jul 24, 2026
K253452 · Accuro 3S
- ROPCA ApSJun 18, 2026
K260190 · ARTHUR
- Edgecare, Inc.Apr 17, 2026
K252237 · EdgeFlow UW20
- Rivanna Medical, Inc.Apr 9, 2026
K254021 · Accuro XV
- QT Imaging Holdings, Inc.Mar 4, 2026
K253898 · QT Scanner 2000 Model A
- Philips Image Guided Therapy CorporationFeb 24, 2026
K253714 · IntraSight Plus
- Eieling Technology (Shenzhen) LimitedFeb 6, 2026
K253221 · Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
- Astrasono Technology Co., Ltd.Sep 30, 2025
K250331 · Astrasono A3Pro Bladder Scanner (A3Pro)