Siemens Medical Solutions USA, Inc. ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
REF/UDI-DI: 11711750/04056869995809
Products Sold
REF/UDI-DI: 11711750/04056869995809, and 11711779/04056869995830. Serial Numbers: 700127 700125 700109 700123 700124 700126 700131 700077 700081 700070 700071 700073 700075 700076 700072 700074 700096 700097 700098 700100 700103 700082 700030 700036 700037 700028 700029 700031 700033 700022 700023 700024 700025 700035 700121 700111 700132 700065 700058 700026 700019 700020 900581 900582 900583 900585 700034 700032 700041 700040 700039 700052 700053 700057 700038 700063 700062 700060 700064 700068 700059 700084 700083 700107 700114 700115 700135.
Siemens Medical Solutions USA, Inc. is recalling ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, runnin due to On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region me. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 2/23/24, correction notices were sent to customers informing them of the following: This issue is specific to and limited to the use of the Cardiac DICOM SR feature: - When a user uses and configures the Cardiac DICOM SR feature to display either the MINIMUM (Min) or the MAXIMUM (Max) measured value, AND - Makes multiple measurements of the cardiac region during an examination, AND - Exports the results into the Cardiac DICOM SR feature, THEN - The Cardiac DICOM SR viewer will NOT display the MINIMUM (Min) or MAXIMUM (Max) value and will instead display the LAST measured value. In that case, the displayed measurement in the Cardiac DICOM SR viewer may NOT be the Minimum (Min) or MAXIMUM (Max) value measured during the examination. To avoid potential misdiagnosis by an over- or underrepresented measured value, it is recommended to refer to the measurement values displayed on the Ultrasound System Final Report when the configuration is to display the Min or Max value. Firm recommends a review of previous cardiac ultrasound examination results where the clinical assessment was reviewed using a DICOM SR viewer. Your Customer Service Engineer from will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by spring/summer of 2024. Please ensure that all users of the affected devices within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. If you have further questions, please contact the firm's Ultrasound Service Customer Care Center at 1-800-888-7436. Not Affected: -ACUSON Juniper Ultrasound System, product version 2.5, software version VB30D. - ACUSON Redwood system, product version 2.0.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026