Events

Recall of Device Recall Biograph mCT Systems:

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    80200
  • Event Risk Class
    Class 2
  • Event Number
    Z-2248-2018
  • Event Initiated Date
    2018-05-29
  • Event Date Posted
    2018-06-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164842
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • 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.
  • Action
    The firm notified the consignees of the issue by email on May 29, 2018. The letter identified the affected product, problem and actions to be taken. They are tracking completion of the letter delivery through the hand-delivered approach. For further questions, please call (847) 304-7700. .

Device

Device Recall Biograph mCT Systems:
  • Model / Serial
    (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 10248672,  Serial Numbers: 1004 11046 11064 11036 11030 11093 11033 11032 11041 11042 11043 11044 11047 11053 11069 11071 11078 11079 11084 11082 11091 11092 21098 21101 21102 21105 21104 1016 11024 11026 11029 11054 11058 11077 11086 11095 11052 11068 11096 11020 11067 11087 11015 1006 1019 11073 11075 11083 21097 11088 21103 1010 11038 11039 11040 11061 11062 11063 11076 11081 21100 11025 11051 11065 11070 11072 11050 11023 1005 11074 11094 1012 11059 11045 1002 1003 1007 1011 1014 1013 1018 11022 11021 11027 11028 11031 11034 11035 11037 11048 11049 11055 11056 11057 11060 11066 11080 11089 11090 21099 1001 1001  (d) Biograph mCT X-4R, Material Number 10248670,  Serial Numbers: 1008 11016 11017 11022 11029 11036 11054 11066 1010 1004 11063 11027 11055 11056 11058 11057 11060 11064 11070 21074 1003 1005 1009 11015 11023 11037 11042 11045 11047 11052 11059 11065 11031 1002 11061 11068 1006 11019 11041 11048 11038 11039 11014 11021 11028 11030 11034 11069 21071 11018 11013 11040 11067 11025 11049 11051 11050 11046 11062 1007 1011 11012 11020 11024 11026 11035 11043 11044 21072 21073 1001  (e) Biograph mCT X-3R, Material Number 10248673,  Serial Numbers: 11010 11013 11011 11009 1006 1002 1007 11012 11015 11017 11016 1003 1004 1005 11020 11008 11019  (f) BIOGRAPH mCT 20 Excel, Material Number 10507786,  Serial Numbers: 11013 11001 11022 11026 11032 11007 11012 11038 11002 11006 11014 11015 11019 11020 11035 11037 11046 11034 11024 11036 11049 11050 11009 11027 11028 11003 11004 11008 11010 11017 11018 11021 11023 11025 11029 11030 11031 11033 11039 11040 11041 11042 11043 11044 11045 11047 21051 21119  (g) Biograph mCT Flow Edge-4R, Material Number 10528955,  Serial Numbers: 11001  (h) Biograph mCT S(40)-3R, Material Number 10248668,  Serial Numbers: 21048 11044 11024 11034 1002 11018 11025 11032 11029 11039 1004 1013 1017 1010 11027 11022 1007 11019 1006 11036 1005 1012 1014 1015 1016 11023 11026 11028 11030 11031 11038 11040 11041 11042 21045 11037  (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743,  Serial Numbers: 1002  (j) Biograph mCT Flow 40-4R, Material Number 10529159,  Serial Numbers: 11001  (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745,  Serial Numbers: 1001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60192-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA