Class 2 Device Recall Siemens Biograph mCT

• Date Initiated by Firm: September 28, 2018
• Create Date: October 18, 2018
• Recall Status: Terminated on February 11, 2021
• Recall Number: Z-0178-2019
• Recall Event ID: 81144
• 510(K)Number: K173578
• Product Classification: System, tomography, computed, emission - Product Code KPS
• 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.
• Code Information: 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: 11009 11014 11016 60016 60029 11010 60027 59001 59002 59003 59004 59005 59006 59007 60022 60025 60026 60028 60033 11026 60006 11003 60013 11015 60015 60019 60024 60034 60032 11020 11019 60020 11024 60012 60030 11011 11012 11004 11005 11006 11008 11023 60001 60002 60003 60011 60021 60008 11001 11002 11007 11013 11017 11018 11021 11022 11025 60004 60005 60007 60009 60010 60014 60017 60018 60023 60031 e) Material Number 10248671 Serial numbers: 11043 11045 11046 11072 11058 11069 1013 11081 40003 59001 59002 11057 31099 31100 1002 1008 1011 1019 11037 11040 11044 11067 11073 60001 1003 1007 1017 11029 11032 11051 11053 11054 11061 11062 11063 11080 91001 1001 11077 1025 11033 11049 11084 21087 21091 40004 1012 1014 1018 11039 11055 11056 11059 11075 11078 21085 21089 21090 21093 31095 40002 11036 1005 11030 11038 11047 11064 11065 21086 31094 31097 60001 60002 90001 11031 11028 11070 1020 11068 31098 11026 21088 31092 1006 1004 1009 1010 1015 1016 1022 1023 1024 11027 11034 11035 11041 11042 11048 11050 11052 11060 11066 11071 11074 11076 11082 11083 31096 40001 f) Material Number 10248672 Serial numbers: 90002 1004 11046 11064 31117 1009 31111 11036 11030 11093 11033 11032 11041 11042 11043 11044 11047 11053 11069 11071 11078 11079 11082 11084 11091 11092 21098 21101 21102 21104 21105 31106 31108 31109 31112 31113 31114 31115 31116 31118 31119 31120 31121 31123 31126 31127 59002 59004 59005 59006 1016 11024 11026 11029 1017 11054 11058 11077 11086 11095 60002 60003 11052 11068 11096 11015 11020 11067 11087 1006 1019 11073 11075 11083 21097 31107 59003 11088 21103 60001 1010 11038 11039 11040 11061 11062 11063 11076 11081 21100 11025 11051 11065 11070 11072 11050 1005 11023 31122 60006 11074 11094 1012 11059 59008 1008 11045 1001 1002 1003 1007 1011 1013 1014 1018 11022 11027 11028 11031 11034 11035 11037 11048 11049 11055 11056 11057 11060 11066 11080 11089 11090 21099 31110 31124 31125 40001 60004 60005 90001 91013 91071 g) Material Number 10534159 Serial numbers: 60006 60011 60013 60001 60003 60002 60005 60012 60004 60007 60008 60009 60010 h) Material Number 10528955 Serial numbers: 11001 11006 11015 11013 11002 11003 11005 11008 11009 60003 60008 60009 11004 11007 11010 11014 60004 60005 60010 11011 59001 60001 60002 60006 60007 11012 i) Material Number 10529158 Serial numbers: 60001 11001 60002 11002 11003 j) Material Number 10529160 Serial numbers: 60001 60003 60005 60007 11001 11006 11011 11012 11007 11003 11002 59001 11009 11010 11004 11005 11008 60002 60004 60006 k) Material Number 10248670 Serial numbers: 1008 11016 11017 11022 11029 11033 11036 11054 11066 31082 1010 31081 59001 1004 11063 11027 11032 11055 11056 11057 11058 11060 11064 11070 21074 31076 31077 31079 31080 31084 31075 1003 1005 1009 11015 11023 11042 11045 11047 11052 11059 11065 11031 1002 11061 11068 1006 11019 11041 11048 60001 11038 11039 11014 11021 11028 11030 11034 11069 21071 59002 11018 60002 11013 11040 11067 11025 11049 11050 11051 59004 11046 11062 59003 1001 1007 1011 11012 11020 11024 11026 11035 11043 11044 21072 21073 31083 40001 40002 l) Material Number 10248673 Serial numbers: 11010 11013 11011 31023 31024 11009 31022 1002 1007 11012 11015 11017 11016 1003 31021 1004 11018 1005 11020 11008 11019 60001 60002 m) Material Number 10534160 Serial numbers: 60003 60004 60005 31002 31001 31004 31003 60002 60006 60007 91108 n) Material Number 10248668 Serial numbers: 21048 11044 11024 11034 1002 11018 11025 11029 11032 11039 1004 1013 1017 1010 11027 31046 11022 31049 1007 11019 11020 1006 11036 1005 1012 1014 1015 1016 11023 11026 11028 11030 11031 11037 11038 11040 11041 11042 21045 31047 60002 o) Material Number 10529159 Serial numbers: 60010 11002 11009 60001 60008 60005 11003 60006 60009 11006 11007 60002 60003 11010 11005 11001 11004 11008 60004 60007 p) Material Number 10528956 Serial numbers: 11008 59002 60004 11005 11007 60003 11002 11001 60007 59001 59003 11003 11004 11006 11009 60002 60005 60006 60008 60009 q) Material Number 10528954 Serial numbers: 11001 11002
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60192-2061
• For Additional Information Contact: 847-304-7700
• Manufacturer Reason for Recall: The terminals on the plug may become loose and overheat.
• FDA Determined Cause: Process control
• Action: The firm, Siemens Healthineers, disseminated the " Customer Safety Advisory Notice" on 09/28/2018 to its customers. The notice described the product, problem and actions to be taken. The notice stated the potential problem and how to identify it. The customers were instructed to do the following: in the event overheating occurs or notice a distinct burning odor; stop use of your system and contact Siemens Healthineers service representatives.The issue will be addressed through a service visit to check if the terminal screws are torqued to the proper specification. If you have any questions, please contact your local Siemens Healthineers service representatives at the following numbers: America: 1-800-888-7436 Europe, Middle East, and Africa: +49 9131 940 4000 Asia and Australia: +86(21)3811 2121
• Quantity in Commerce: 890 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = Siemens Medical Solutions USA, Inc.