FDA Device recall Z-2248-2018

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow sys…

FDA Device
Class II
terminated
Published 2018-06-27

On 2018-06-27 the FDA classified a Class II recall of Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow sys… by Siemens Medical Solutions Usa, citing siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biog….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2248-2018
Classification	Class II
Status	terminated
Initiated	2018-05-29
Published	2018-06-27
Last updated	2026-09-13 11:54 UTC
Company	Siemens Medical Solutions Usa
Distribution	n/a

Product

Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745

Reason

Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.

Identifiers

code_info	(a) Biograph mCT S(64)-3R, Material Number 10248669, Serial Numbers: 1006 11025 11015 11021 11012 11016 11019… (a) Biograph mCT S(64)-3R, Material Number 10248669, Serial Numbers: 1006 11025 11015 11021 11012 11016 11019 1003 1004 11010 11014 11032 1005 11027 11017 11022 11033 11020 11011 21036 11018 11009 11013 11023 11024 11026 11028 11029 11030 11031 21034 31055 (b) Biograph mCT S(40)-4R, Material Number 10248671, Serial Numbers: 11043 11045 11046 11072 11058 11069 1013 11081 11057 1002 1008 1011 1019 11037 11040 11067 11073 1003 1007 1017 11029 11032 11051 11054 11061 11062 11063 11080 11053 1001 11077 1025 11033 11049 11084 21087 21091 1012 1014 11039 11055 11056 11059 11075 11078 21085 21089 21090 1018 11036 1005 11038 11047 11064 11065 21086 11031 11028 11070 1020 11068 11026 21088 1006 1004 1009 1010 1016 1015 1022 1023 1024 11027 11034 11035 11041 11042 11048 11050 11052 11060 11066 11071 11074 11076 11082 11083 (c) Biograph mCT S(64)-4R, Material Number 10

code_info

(a) Biograph mCT S(64)-3R, Material Number 10248669, Serial Numbers: 1006 11025 11015 11021 11012 11016 11019…

(a) Biograph mCT S(64)-3R, Material Number 10248669, Serial Numbers: 1006 11025 11015 11021 11012 11016 11019 1003 1004 11010 11014 11032 1005 11027 11017 11022 11033 11020 11011 21036 11018 11009 11013 11023 11024 11026 11028 11029 11030 11031 21034 31055 (b) Biograph mCT S(40)-4R, Material Number 10248671, Serial Numbers: 11043 11045 11046 11072 11058 11069 1013 11081 11057 1002 1008 1011 1019 11037 11040 11067 11073 1003 1007 1017 11029 11032 11051 11054 11061 11062 11063 11080 11053 1001 11077 1025 11033 11049 11084 21087 21091 1012 1014 11039 11055 11056 11059 11075 11078 21085 21089 21090 1018 11036 1005 11038 11047 11064 11065 21086 11031 11028 11070 1020 11068 11026 21088 1006 1004 1009 1010 1016 1015 1022 1023 1024 11027 11034 11035 11041 11042 11048 11050 11052 11060 11066 11071 11074 11076 11082 11083 (c) Biograph mCT S(64)-4R, Material Number 10

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2248-2018%22

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