openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 5
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.
Possibility for system display freeze during CT interventional procedures.
Code information
Serial Numbers: 11002, 11005, 11006, 11008
Distribution pattern
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
device · product 2 of 5
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.
Possibility for system display freeze during CT interventional procedures.
Code information
Serial Number: 11002
Distribution pattern
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
device · product 3 of 5
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.
Possibility for system display freeze during CT interventional procedures.
Code information
Serial Number: 1003
Distribution pattern
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
device · product 4 of 5
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.
Possibility for system display freeze during CT interventional procedures.
Code information
Serial Number: 11021
Distribution pattern
Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
device · product 5 of 5
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.
