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ACUSON Maple Diagnostic Ultrasound System, REF: 11711750… recallZ-1601-2024 · Siemens Medical Solutions USA, Inc. · initiated Feb 23, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1601-2024
Status
Open, Classified
Initiated by the company
Feb 23, 2024
Posted by the FDA
Apr 19, 2024
Recalling firm
Siemens Medical Solutions USA, Inc.
Quantity
67
Product code
IYN
FDA submissions
K232617
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 description

ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94211).

Sources and updates

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