Z-1081-2013Class II

Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI...

Name: Z-1081-2013 Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2013-03-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-03-28 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system... on 2013-03-28. FDA classified it as Class II and gives the reason as "When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1081-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-04-10
Terminated: 2014-02-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA Inc. sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A return response form is included for customers to complete and mail to the recalling establishment. Siemens stated additional follow up action will occur, once material is available, where Siemens field service engineers will visit each unit and replace the affected MPI 4 board. For further questions please call (650) 694-5747.
Quantity in commerce: 120 units
Distribution: Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.
Product codes and lots: All units of this model.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1081-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-10

Product code IYN

K123622Class IIAcusonSiemens Medical Solutions USA, Inc. / cleared 2012-12-05

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)