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Siemens Medical Solutions USA, Inc. recalls Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tom
Recalled January 16, 2019 · FDA recall Z-0707-2019 · Siemens Medical Solutions USA
Hazard
Improper design or specifications. · FDA Class II
Units
171
Sold at
Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom
Description
Improper design or specifications.
Product
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →