Siemens recalls ACUSON Redwood 1.0 and 2.0 ultrasound systems with specific software versions that may convert liters to milliliters incorrectly, risking misdiagnosis. Affected units must be checked for software version and UDI.
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 Redwood 1.0 and 2.0 ultrasound systems with certain software versions that could convert liters to milliliters incorrectly. This might lead to misdiagnosis or improper patient care if the system is used without correction.
The ultrasound systems may convert liters to milliliters using a multiplier of 100 instead of 1000 when software is changed from factory defaults. This results in values 10 times smaller than actual, potentially causing misdiagnosis or incorrect patient management decisions.
Healthcare providers using Siemens ACUSON Redwood ultrasound systems with specific software versions are most at risk. Patients receiving scans from these systems could be affected if misdiagnosis occurs.
Check for software versions VA10G or earlier on 1.0 systems and VA20K or earlier on 2.0 systems. The unique device identifier (UDI) 04056869251264 indicates affected units.
Identify the software version on your ACUSON Redwood system to confirm if it is affected (VA10G or earlier for 1.0, VA20K or earlier for 2.0).
Affected software versions are VA10G or earlier for ACUSON Redwood 1.0 and VA20K or earlier for ACUSON Redwood 2.0.
Check your system's software version and unique device identifier (UDI) 04056869251264. Affected units have specific software versions listed in the recall.
No action is needed if your system's software version is newer than VA10G (for 1.0) or VA20K (for 2.0).
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-3216-2024 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-3216-2024 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.
