Siemens recalls ACUSON Juniper 1.0-2.5 ultrasound systems with specific software versions due to potential misdiagnosis from incorrect unit conversions. Affected units may show values 10x smaller than actual liters.
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 Juniper 1.0, 1.5, 2.0, and 2.5 diagnostic ultrasound systems with certain software versions. These systems could convert liters to milliliters incorrectly, showing values 10 times smaller than actual, which might lead to misdiagnosis or improper patient care.
If the ultrasound system is changed from factory settings to use milliliters per second or milliliters per minute, it will convert liters to milliliters using a multiplier of 100 instead of 1000. This causes results to be 10 times smaller than they should be, potentially leading to misdiagnosis or inappropriate patient treatment decisions.
Healthcare providers using Siemens ACUSON Juniper ultrasound systems with specific software versions are affected. Patients receiving scans from these systems may be at risk of misdiagnosis due to incorrect unit conversions.
Check for the model numbers 1.0, 1.5, 2.0, or 2.5 with specific software versions referenced in the recall notice. The unique identifiers (UDI-DI) listed in the recall include 04056869152059 for 1.0/VA10G and earlier models, and 04056869957357 for 2.0/VB11C and earlier models.
Verify if your ultrasound system has been modified from factory default to use milliliters per second or milliliters per minute.
The recall covers specific software versions that have been changed from factory default to use milliliters per second or milliliters per minute. Exact versions are listed in the unique identifiers (UDI-DI) provided in the recall notice.
Incorrect unit conversions could result in values 10 times smaller than actual, potentially leading to misdiagnosis or inappropriate patient management decisions.
The recall does not specify a remedy, so no action is required beyond checking if your system has been modified from factory settings.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-3215-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-3215-2024 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.
