FDA-Device2014-02-05Class II
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
Siemens Medical Solutions USA, Inc.
Hazard
The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, 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.
Affected count
271 units
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2014Don't want to check this manually?
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