Z-1601-2024Class II

ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running...

Name: Z-1601-2024 ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2024-02-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2024-02-23 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A on 2024-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1601-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-23
Posted: 2024-04-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 67
Distribution: Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1601-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1599-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-19
Z-1600-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-19
Z-1601-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-19

Product code IYN

K232617Class IIACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2023-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)