Siemens recalls ACUSON Sequoia ultrasound systems with specific equipment serial numbers due to potential incorrect Estimated Date of Delivery calculations, which could lead to premature births. Affected units include those with serial numbers listed in the recall notice.
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.
Siemens is recalling certain ACUSON Sequoia ultrasound systems that may incorrectly calculate the estimated date of delivery (EDD) for pregnancies. This could lead to premature births if healthcare providers rely on the inaccurate date for decisions about labor induction or cesarean sections.
The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This averaging process may result in an incorrect EDD, which could influence decisions about labor induction or cesarean delivery, potentially leading to premature births.
Pregnant individuals using the ACUSON Sequoia ultrasound system with the listed equipment serial numbers are most at risk. Healthcare providers using the system for patient monitoring may also be affected.
Check if your ACUSON Sequoia ultrasound system has equipment serial numbers listed in the provided range (e.g., 800015 to 802273). The product label includes the model number 11148775 and power specifications.
Verify if your ACUSON Sequoia ultrasound system has an equipment serial number listed in the provided range (e.g., 800015 to 802273).
The recalled model is the ACUSON Sequoia ultrasound system with equipment serial numbers listed in the provided range (e.g., 800015 to 802273).
Check the equipment serial number on your device against the list of affected serial numbers provided in the recall notice.
The recall does not specify a remedy, so you should check with Siemens Medical Solutions USA, Inc. for further instructions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1330-2021 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1330-2021 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.
