Siemens Medical Solutions USA Inc.: Possibility for system display freeze during CT interventional procedures.

Agency Publication Date: December 16, 2014

Affected Products

Product: Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT 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.

Serial Numbers: 11002, 11005, 11006, 11008

Product: Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT 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.

Serial Number: 11002

Product: Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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.

Serial Number: 1003

Product: Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT 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.

Serial Number: 11021

Product: Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT 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.

Serial Number: 11042

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69897

Status: Resolved

Manufacturer: Siemens Medical Solutions USA Inc.

Manufactured In: United States

Units Affected: 5 products (4 units; 1 unit; 8 units total; 8 units total; 8 units total)

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Sources: FDA iRES · Raw API Response

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