Devices

Device Recall SKYLight

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 882420;  Model number (8 FT 3/8): 2161-3000B, 4535-602-46831; Serial numbers: 2000149 2000154 2000158 2000168 2000170 2000172 20007040128 K06010056 K06030067 K06010056 K06030067 2000146 2000152 2000155 2000156 2000161 2000162 2000163 2000164 2000166 2000169 2000173 2000174 2000176 2000181 2000182 2000183 2000185 2000186 2000187 2000188 2000191 20002080145 20006120113 20006120114 20007010115 20007010116 20007020117 20007020118 20007020120 20007020122 20007030123 20007030125 20007050130 20007050131 20007050132 20007050133 20007060134 20007060135 20007060136 20007070138 20007070140 20007080144 K04110001 K05010003 K05010004-1 K05010005 K05030007 K05030009 K05030010 K05030011 K05040012-1 K05040013 K05040014 K05040015 K05040016 K05050019 K05050020 K05060022 K05060023 K05060024 K05060026 K05060027 K05070028 K05070029 K05070032 K05080034 K05080036 K05080037 K05080038 K05090040 K05090043 K05090044 K05090045 K05100046 K05100047 K05100048 K05110029 K05110051 K05110052 K06010057 K06010058 K06010060 K06020062 K06020063 K06020064 K06020065 K06030003 K06030066 K06030068 K06040071 K06040073 K06040074 K06040075 K06040077 K06050078 K06050079 K06060080 K06060081 K06060082 K06070083 K06070084 K06070085 K06070086 K06080087 K06080088 K06080090 K06080091 K06080094 K06080095 K06080097 K06090099 K06090100 K06090103 K06100105 K06100106 K06100107    Model number (8 FT 5/8); 2160-3001B, 4535-602-55271;Serial numbers: K03020003  Model number (9 FT 3/8): 2161-3000B; 4535-602-46641; Serial numbers: K05060019 K05070022 K05060019 K05070022 K05060019 K05070022 K05060019 K05070022 20006120064 20007010065 20007010065 K05010004 K05020008 K05020009 K05040012 K05040013 K05050015 K05050016 K05060018 K05060020 K05070023 K05110029 K06010031 K06010031 K06070049 K06080051 K06080052 K06090053 K06090054 K06100055 K06100056 K06100058    Model number (9 FT 5/8): 2160-3001B. Serial numbers:
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". || Philips Medical Systems || Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems
  • 1 Event

제조사

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

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Device Recall SKYLight Imaging Systems
  • 모델명 / 제조번호(시리얼번호)
    Model numberL 882050; Code numbers: K01110023 K02040041, K02050049 K03050121 K02030032 K01070004 K02080079 K02100095 K02030033 K02030034 K01070003 K02070068 K02080075, K02080082 K01090015 K01080005 K02080077 K01080009 K01100016 K02050058 K02070065 K02080078 K02030035 K02070070 K01100019 K01110027 K01110021 K02100092 K02090087 K02060061 K03060124 K02040040 K02030037 K02100094 K02070063 K01100017 K01110025 K02050052 K03080132 K02040043 K01090012 K03030112 K01100020, K02070064 K03070128 K03040115 K01080008 K02090084, K03030108 K02100098 K01110022 K01110024 K02050048 K02090088 K03050119 K03030107 K02050055 K01090011 K03060122 K02070062 K02040047 K01090010 K02050059 K03040116 K02050054 K03030109 K03080134 K02030038 K03080133 K02070072, K02080081 K02100091 K02060050 K02020029 K03030114 K02100096 K02070071 K03040117 K03060123 K01080006 K03030135 K03080135 K01080007 K02020030, K02040045 K02070067 K02020031 K03070125 K02030036 K02070066 K02090083 K02100090 K02090089 K02110097 K02120104 K02120106 K03070129 K03070130 K02080074 K02120105 K02040042 K03040118 K02110101 K02120103 K03050120 K02110102 K02110001 K03070131 K02050053 K03070126 K02040044 K03030113 K03030110 K03030111 K02070073 K02050056 K02110100 K02050050 K02040046 K01090013 K03070127 K01110028 K02050051 K02030039 K02080076 K02050057 K02090085
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Italy, Spain, France, United Kingdom, Sweden, Switzerland, Germany, Japan, Denmark, and the Netherlands.
  • 제품 설명
    SKYLight Imaging Systems, Model 882050; || Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems
Device Recall SKYLight
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 882050;  Model number (8 FT 3/8): 2161-3000A, Serial numbers: K03100064 K03100065 K04120121 K04120122 K03050033 K03080053 K03080054 K03090055 K03090056 K03090057 K03090058 K03090059 K03090060 K03100061 K03100062 K03100063 K04010069 K04010070 K04010074 K04020072 K04020073 K04020074 k04030076 K04030075 K04030077 K04030078 K04030080 K04040081 K04040082 K04040083 K04040084 K04050086 K04050087 K04050088 K04060089 K04060090 K04070099 K04080100 K04080101 K04080102 K04090103 K04090104 K04090105 K04090108 K04090109 K04100110 K04100111 K04100112 K04110113 K04110115 K04110116 K04110119 K04120120 K04120123 K04120124 K04120125 K04120126 K04120120 K04120120.  Model number (9 FT 3/8); 2160-3000A; Serial Numbers: K03080136 K03090138 K03100140 K03100142 K03110143 K03110144 K03110145 K03110146 K03110147 K03120148 K04010150 K04010152 K04010153 K04030155 K04030157 K04030158 K04060166 K04060167 K04070168 K04070169 K04070170 K04080172 K04090178 K04100183 K04100186.  Model number (8 FT 5/8): 2161-3001A; Serial numbers: K03020003.  Model number (9FT 5/8): 2160-3001A. 11131
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT. || Philips Medical Systems || Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
  • Manufacturer
    Philips Medical Systems