FDA Device recall Z-0178-2019
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 Fl…
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of 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 Fl… by Siemens Medical Solutions Usa, citing the terminals on the plug may become loose and overheat.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-28 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
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.
Reason
The terminals on the plug may become loose and overheat.
Identifiers
| code_info | Biograph mCT: a) Material Number 10248669 Serial numbers: 1006 1007 11025 31043 60012 60013 31049 31052 3105…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 |
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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-0178-2019%22
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