ACUSON Maple Ultrasound (Siemens) - Software Measurement Error (2024)
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 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
11711750, UDI-DI: 04056869995809, Software VA10A 11711779, UDI-DI: 04056869995830, Software VA10A
Products Sold
11711750, UDI-DI: 04056869995809, Software VA10A 11711779, UDI-DI: 04056869995830, Software VA10A
Siemens Medical Solutions USA, Inc. is recalling ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 8/15/2024, correction notices were distributed to customers who were asked to do the following: To avoid potential misdiagnosis by an under-represented volume flow measurement value, use the factory default display configuration of l/min (liters per minute). Review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in milliliters. Firm's Customer Service Engineer 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 in the summer of 2024. Ensure that all users of ACUSON Juniper and ACUSON Maple systems 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.
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 noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, RI, SC, SD, TN, TX, VA, WA, WI, WY, PR
Page updated: Jan 10, 2026