Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S
Medical device recall Z-0178-2019. Published in FDA’s Enforcement Report on Oct 24, 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 Oct 24, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 890 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?
The terminals on the plug may become loose and overheat.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10529159 p) mCT Flow 20-3R, Material Number 10528956 q) mCT Flow Edge-3R, Material Number 10528954 The Siemens Biograph Horizon and 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.
890 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Biograph mCT: a) Material Number 10248669 Serial numbers: 1006 1007 11025 31043 60012 60013 31049 31052 31053 11015 11021 59001 11012 11016 60014 11019 1003 1004 11010 11014 11032 1005 31045 31047 31048 31050 31051 11027 11017 11022 11033…
Every code shown here, 1,997 characters
Biograph mCT: a) Material Number 10248669 Serial numbers: 1006 1007 11025 31043 60012 60013 31049 31052 31053 11015 11021 59001 11012 11016 60014 11019 1003 1004 11010 11014 11032 1005 31045 31047 31048 31050 31051 11027 11017 11022 11033 31041 60009 60011 11011 21036 11018 11009 11023 11024 11026 11028 11029 11030 11031 21034 31037 31038 31039 31040 31042 31044 31046 31054 31055 60001 60002 60003 60004 60005 60006 60007 60008 60010 b) Material Number 10507786 Serial numbers: 21067 21089 21101 11013 21110 21120 21073 21077 21128 21131 21138 59003 59004 60024 21147 11001 21092 21105 21115 21123 59002 59005 59006 59008 21071 21082 11022 11026 21150 11032 21075 21080 11007 11012 21106 21140 60020 21107 21149 60011 21056 21135 21065 21117 21127 60014 11038 21060 21087 21094 21100 21122 21144 60001 11002 11006 11014 11015 11019 11020 11035 11037 11046 21058 21072 60003 21145 21059 21095 21103 21139 21146 21052 21053 21104 21109 21133 60008 11034 21111 21112 11009 11024 11027 11028 11036 11049 11050 21054 21057 21061 21062 21066 21068 21076 21078 21090 21091 21093 21098 21118 21134 21137 11003 11004 11008 11010 11017 11018 11021 11023 11025 11029 11030 11031 11033 11039 11040 11041 11042 11043 11044 11045 11047 21051 21055 21063 21064 21069 21070 21074 21079 21081 21083 21084 21085 21086 21088 21096 21097 21099 21102 21113 21114 21116 21119 21121 21124 21126 21129 21130 21132 21136 21141 21142 21151 60002 60004 60005 60006 60007 60009 60010 60012 60013 60015 60016 60017 60018 60022 60023 60025 60026 60027 60029 60030 60031 60032 60034 60021 c) Material Number 10528958 Serial numbers: 60004 60027 60018 11005 60017 60011 60019 11004 11002 11003 11007 11009 11010 11014 11015 11016 11017 11020 11021 11023 60001 60002 60007 60008 60021 11018 11026 11001 11008 11011 11012 11019 11030 60009 60010 60013 60016 60028 11013 60015 60029 60025 11006 11022 11024 11025 11027 11028 11029 60003 60005 60006 60012 60014 60020 60022 60023 60024 d) Material Number 10529161 Serial numbers:…
FDA’s list runs to 6,026 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: US (nationwide) and countries of: Argentina, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Brunnel, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Republic Korea, Lebanon, Sri Lanka, Macedonia, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, Switzerland, Thailand, Turkey, Taiwan, UAE, United Kingdom and Vietnam.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Sep 28, 2018.
- FDA classified it on Oct 18, 2018.
- FDA’s Enforcement Report published it on Oct 24, 2018.
- FDA terminated it on Feb 11, 2021.
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: Letter.
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 6,026 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.