Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1056-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 12, 2015

Date Posted: February 11, 2015

Recall Number: Z-1056-2015

Event ID: 70362

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.

Status: Terminated

Product Quantity: 230

Code Information:

Model number 10433816. serial numbers 401100 to 401400.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated