Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

Recall date
March 5, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1200-2018
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc.
Sold / distributed
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, G…

Why it was recalled

The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

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