Z-1056-2015Class II

ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging...

Name: Z-1056-2015 ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2015-01-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-01-12 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the following applications... on 2015-01-12. FDA classified it as Class II and gives the reason as "The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position". 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-1056-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-12
Posted: 2015-02-05
Terminated: 2015-11-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. 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: The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens Medical sent an Customer Safety Advisory Notification to all affected customers on January 12, 2015 , via Certified mail, return receipt requested.The letter identified the product the problem and the action needed to be taken by the customer. At this time there is not mitigation to avoid risk associated with this issue. Local Customer Service Engineers will be contacting each site to replace the console. Until the necessary repairs have been completed, please share the information with all uses of the device. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a very high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. We sincerely regret any inconvenience this condition may cause in your daily operations. For further questions please call (650) 694-5398.
Quantity in commerce: 230
Distribution: Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.
Product codes and lots: Model number 10433816. serial numbers 401100 to 401400.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1056-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1056-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)