Siemens Medical Solutions USA, Inc. 10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Model number 10032746
Products Sold
Model number 10032746
Siemens Medical Solutions USA, Inc. is recalling 10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain due to ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
Recommended Action
Per FDA guidance
The firm's Customer Safety Advisory notice was mailed to all affected customers. The letter describes when the malfunction occurs and the potential risk. It also recommended that users collect corresponding evidence with spectral waveforms that would confirm or deny findings based on ECG, in order to avoid potential risks for misdiagnosis. The firm planned to exchange the faulty hardware component in the system. Customers would be contacted to schedule for the hardware exchange. Questions regarding this issue should be directed to the local service support person.
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 noticePage updated: Jan 10, 2026