Z-1007-2011

10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA

Name: Z-1007-2011 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-10-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-10-02 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA on 2009-10-02. The reason FDA records is "ECG waveform does not accurately align with 2D, M-Mode or Spectral Images". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1007-2011
Status: Terminated
Initiated: 2009-10-02
Posted: 2011-02-01
Terminated: 2011-03-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 67 units total
Distribution: Worldwide Distribution
Product codes and lots: Model 10430054

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)