FDA-Device2018-05-16Class II
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Siemens Medical Solutions USA, Inc.
Hazard
The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
Sold states
Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Belgium, Bosnia Herzeg, Colombia, Croatia, Denmark, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, New Zealand, Philippines, Poland, Republic Korea, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, and Vietnam.
Affected count
229 systems
Manufactured in
685 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2018Don't want to check this manually?
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