Siemens recalls ACUSON Maple 1.0 diagnostic ultrasound systems with specific software versions due to potential misdiagnosis from incorrect unit conversions. Affected units may display 10x smaller values than actual, risking patient management errors.
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
Siemens is recalling ACUSON Maple 1.0 diagnostic ultrasound systems with certain software versions because they may convert liters to milliliters incorrectly. This could lead to misdiagnosis or improper patient care if the unit is used without proper calibration.
The ultrasound system may convert liters to milliliters using a multiplier of 100 instead of 1000. This causes the displayed values to be 10 times smaller than the actual measurements, potentially leading to misdiagnosis or improper patient management decisions.
Healthcare providers using the ACUSON Maple 1.0 ultrasound systems with specific software versions are most at risk. Patients receiving care from these systems could be affected if misdiagnosis occurs due to incorrect unit conversions.
Check for the ACUSON Maple 1.0 Diagnostic Ultrasound System with software version VA10A (reference numbers 11711750 or 11711779). The system may have a unique identifier (UDI-DI) starting with 04056869995809 or 04056869995830.
Verify the software version on your ACUSON Maple 1.0 system; affected units have software version VA10A.
Affected units have software version VA10A.
Check for the ACUSON Maple 1.0 Diagnostic Ultrasound System with software version VA10A and unique identifiers starting with 04056869995809 or 04056869995830.
The recall record does not specify a remedy or fix for the software issue.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-3217-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-3217-2024 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.