System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions Usa, Inc.'s record for this product code
Recent MDR events
448 adverse event reports on file
- ACUSON JUNIPER ULTRASOUND SYSTEMJun 24, 2026Malfunction3023245-2026-00044
- SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONICMay 22, 2026Malfunction3023245-2026-00039
- SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONICMay 20, 2026Malfunction3023245-2026-00038
- ACUSON SC2000 ULTRASOUND SYSTEMMay 19, 2026Malfunction3023245-2026-00035
- ACUSON SC2000 ULTRASOUND SYSTEMMay 19, 2026Malfunction3023245-2026-00036
- ACUSON SC2000 ULTRASOUND SYSTEMMay 19, 2026Malfunction3023245-2026-00037
- SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONICMay 15, 2026Malfunction3023245-2026-00034
- ULTRASOUNDApr 7, 2026Malfunction3023245-2026-00031
- ULTRASOUNDApr 7, 2026Malfunction3023245-2026-00030
- ACUSON ORIGINApr 7, 2026Malfunction3023245-2026-00032
Recalls
63 recall events for this product code
- Open, ClassifiedSep 24, 2024
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
View FDA record ↗ - Open, ClassifiedSep 24, 2024
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
View FDA record ↗ - Open, ClassifiedSep 24, 2024
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
View FDA record ↗ - Open, ClassifiedApr 19, 2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
View FDA record ↗ - Open, ClassifiedApr 19, 2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
View FDA record ↗ - Open, ClassifiedApr 19, 2024
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
View FDA record ↗ - Open, ClassifiedSep 13, 2023
If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way.
View FDA record ↗ - Open, ClassifiedApr 27, 2022
Transducers (component of ultrasound system) may exceed recommended thermal index limits
View FDA record ↗ - TerminatedMar 26, 2018
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
View FDA record ↗ - TerminatedNov 28, 2016
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
View FDA record ↗
510(k) clearances
88 clearances for this product code
- K260844Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
- K253487Nov 17, 2025
ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
- K253457Nov 13, 2025
ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
- K251481Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
- K242523Nov 19, 2024
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System
- K243299Nov 15, 2024
ACUSON Redwood Diagnostic Ultrasound System
- K240704Jul 22, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
- K233610Jun 12, 2024
ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
- K232145Oct 30, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
- K232617Sep 26, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System