Device 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.
Z-1056-2015
Product summary
- Event
- Event 70362
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230
- Official record key
device-enforcement:Z-1056-2015
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.