Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph…
Medical device recall Z-2248-2018. Published in FDA’s Enforcement Report on Jun 27, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 27, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 405 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
405 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 1,992 characters
(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,…
FDA’s list runs to 3,079 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 29, 2018.
- FDA classified it on Jun 18, 2018.
- FDA’s Enforcement Report published it on Jun 27, 2018.
- FDA terminated it on Aug 24, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Hoffman Estates, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,079 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.