Events

Recall of Discovery NM/CT 670

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69570
  • Event Risk Class
    Class 2
  • Event Number
    Z-0186-2015
  • Event Initiated Date
    2014-10-14
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130970
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Ge is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. ge is updating the preventative maintenance procedure and schedule, and added an additional preventative maintenance check for loose fasteners on the nuclear medicaine systems.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.

Device

Discovery NM/CT 670
  • Model / Serial
    21111 DUKECCDSV670NM 21189 DUKEDMP670NM 21223 307362D670 21224 660890D670 21079 0910267022 00000000103BH2 0910263259 00000000124BH8 83092327843 00000000129BH7 83092719500 00000087514HL6 83092962829 00000097761HL1 83095572382 00000333837HM3 83091096402 21215 100039NU02 21229 210002NU11 21220 BY4033NM01 21166 82426070031 21213 82426040052 21222 082426040053 21231 082426070034 21230 082426080022 21226 TP0007NU02 21155 IE1018MN03 092302HL9 KW1001NM01 092303HL7 KW1112NM04 092307HL8 KW1112NM03 21148 ZWL0630 00000093649HL2 QA1064NM01 21173 RU2581NM01 21190 RU7174NM01 00000290644HM4 RU1493NM01 00000322039HM9 SA1006NM01 095718HL3 SA2315NM01 21219 0847260029 21218 M001NU43 21177 475260NU01 21234 00242NUC06 SAN00200 00258NUC02 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21114 614NCH670 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21188 415353D670 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 SAN00215 615893MMCT1 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 00000000096BH8 0910265076 21001 010120NU19 21008 110022NU05 21034 030133NU13 21050 210060NU02 21056 110017NU06 21104 030082NU13 21132 100032NU05 21162 190163NU04 21167 190163NU06 21178 080041NU04 21179 030360NU01 21214 030037NU08 210088 190052NU09 21164 BG4009NM01 21042 204726D670NM 21048 514848D670 21058 AM1-122ANKH9  21061 514281D670 21077 514842AD670 21085 905883D670 21094 519973D670 21115 613548D670 21122 418549D670A 21123 418549D670B 21135 905684D670A 21137 514338D670 21139 905684D670B 21143 250370D670 21156 905472D670 21184 403943D670 21194 403943D670B 21198 819563D670B 21200 403343D670 21210 514876D670 000CZC11601GV 416495D670 21028 082426130029 21052 082426070028 21076 082426080020 21083 082426040043 21092 082426070030 21101 082426130030 21113 082426040044 21118 082426090029 21131 082426150026 21138 082426090030 21165 082426210020 21183 082426160042 21207 082426230020 21212 082426100052 21158 082426060005 21168 082426040051 21019 DK1029NU14 21055 DK1047NM01 21154 EE1020NM03 21009 FI1052MN01 21021 M4210246 21022 X102874005 21033 M4134637 21035 M9409545 21037 M4198090 21063 M4505290 21064 M5172553 21067 M9886847 21070 M2002713 21073 X4144501 21086 M4143630 21095 M4476424 21121 M5480777 21128 M251400603 21134 A4194844 21141 A4169312 21146 M4145158 21152 V4144610 21153 M5400562 21159 M4215577 21186 M4194042 21187 M4144126 21197 V4169306 21206 M4143993 21216 B4182011 21024 UX2305NU01 21196 PC8262NU01 21093 GP1000NM01 21170 0828260021 21199 0828260022 21004 083026201006810 21014 083026009408410 21053 083026023683711 21031 IL1041NM30 21129 IL1062NM29 00ME1 IL1020NM36 21012 A5129983 21059 A51142126 21151 B5140618 21163 A51051127 21185 A5125139 21205 A5196344 21089 NT1001 21097 NT1002 21100 NT2001 21136 NT1006 00000000081BH0 NT1003 00000000082BH8 NT1004 00000000092BH7 NT1005 00000000093BH5 NT1007 00000000101BH6 NT1010 00000000102BH4 NT1011 00000000106BH5 NT2002 00000000110BH7 NT1020 00000000111BH5 NT1009 00000000122BH2 NT1013 00000000123BH0 NT1015 00000326277HM1 NT1012 21016 0850260118 21040 0850260122 21060 0850260131 21103 0850260128 21125 0850260132 21038 RTD0737 21204 AMS1330 21209 HOR0281 00000000118BH0 0920269097 21068 NO1087MN09 21126 NO1018MN06 21211 NO1088MN16 21026 600092NM11 21011 RU3451NM01 21018 RU3637PT01 21025 RU3623NM01 21071 RU3713NM01 21087 RU1949NM01 21090 RU3900NM01 21098 RU7505NM01 21109 RU7187NM01 21110 RU6340NM01 21130 RU7175NM01 21142 RU1095NM03 21160 RU3467NM01 21161 RU3880NM01 21180 RU1279NM02 21195 GON4061978 00000093077HL6 SA1034NM01 00000321622HM3 SA2281NM01 21007 MEX68915 21047 FE416061 21175 D007NU12 21203 M001NU42 21217 O005NU27 21005 529150NU05 21072 900010NU09 21191 260010NU06 21099 0853260094 21171 0853260099 21096 0856260034 21107 0856260033 21169 0856260035 21091 06007NUC19 21003 00200NUC07 21006 00200NUC08 21010 00361NUC08 21027 00046NUC06 21036 00042NUC02 21043 10497NUC20 21046 00065NUC08 21051 00028NUC01 21084 00001NUC12 21108 00197NUC14 21116 00199NUC13 21120 11018NUC08 21124 00432NUC02 21133 00123NUC01 21176 00234NUC09 21181 05462NUC05 21192 00271NUC07 21208 00149NUC03 21225 00310NUC06 21227 00149NUC01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.
  • Product Description
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. || Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA