Z-2149-2011

4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number...

Name: Z-2149-2011 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-07-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-07-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical... on 2009-07-10. The reason FDA records is "Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature". 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-2149-2011
Status: Terminated
Initiated: 2009-07-10
Posted: 2011-05-05
Terminated: 2011-05-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA. The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.
Reason for recall: Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.
Quantity in commerce: 42 units
Distribution: Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
Product codes and lots: seial numbers

K072365Class IISequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2007-10-17

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)