Events

Rappel de Device Recall Optima CL323i

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Medical Systems, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72740
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0413-2016
  • Date de mise en oeuvre de l'événement
    2015-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142057
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, angiographic - Product Code IZI
  • Cause
    Ge healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving optima cl323i & optima igs 320 systems .
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#12237 dated November 13, 2015 to customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall Optima CL323i
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1 00000097546HL6 631654INNOVA 00000097777HL7 937592OPT 00000098434HL4 504568INNOVA41 00000098435HL1 702616RDL31 00000098828HL7 843339INNOVA2 00000098977HL2 202269INNOVA 00000099837HL7 520417OPT3100 00000101009HL9 308865KR31 00000101825HL8 216778LABC 00000112807HL3 517353CATH 00000115275HL0 407CCE323 00000116573HL7 509837SSCL1 00000117808HL6 GON4173729 00000118032HL2 812284IN31 00000118368HL0 318330INNOVA1 00000118712HL9 361788CL323 00000118714HL5 806358INNOVA 00000119286HL3 912384CL 00000119585HL8 GON4263188 00000120996HL4 GON4263188 00000121694HL4 229890CL 00000121719HL9 520GVHCATH 00000124905HL1 217443PUSAM323 00000124965HL5 941483CL1 00000126533HL9 702880CATH1 00000127011HL5 318704CATH2 00000110028HL8 DZ1605VA01 00000108050HL6 082416090051 00000112754HL7 082416230024 00000113435HL2 GON4217188 00000113700HL9 082416010027 00000113963HL3 082416090050 00000113977HL3 082416090047 00000116179HL3 082416090058 00000116903HL6 082416100086 00000117226HL1 082416090053 00000117334HL3 082416120042 00000117414HL3 GON4229674 00000117572HL8 GON4242594 00000119287HL1 082416090062 00000119871HL2 082416210033 00000120419HL7 082416190023 00000120578HL0 082416190021 00000120736HL4 082416090059 00000120847HL9 082416090064 00000120867HL7 082416100085 00000120982HL4 082416060016 00000121662HL1 082416090067 00000122668HL7 082416140017 00000122850HL1 082416250010 00000123076HL2 082416180016 00000123319HL6 082416310033 00000123501HL9 082416050013 00000123712HL2 082416200021 00000124692HL5 082416190022 00000125706HL2 082416100095 00000125713HL8 082416190024 00000125813HL6 082416030027 00000125876HL3 082416030028 00000125896HL1 082416110023 00000126170HL0 082416070041 00000126248HL4 082416010028 00000126340HL9 082416200020 00000126419HL1 082416100096 00000126437HL3 082416100093 00000126690HL7 082416090069 00000126899HL4 082416240010 00000127446HL3 082416090071 00000127737HL5 GON4336456 00000127862HL1 082416290009 00000128225HL0 082416250011 00000128502HL2 082416210035 00000128654HL1 082416070045 00000128767HL1 082416160051 00000128873HL7 082416070044 00000128977HL6 082416020018 00000129200HL2 082416030030 00000129201HL0 082416110027 00000127175HL8 GON4272817 00000121740HL5 GE1161VA01 00000124022HL5 083016843923015 00000122051HL6 0835160056 00000126571HL9 A5185810 00000100200HL5 LB1064VA02 00000121474HL1 LB1001VA01 00000108264HL3 MQ1008VA02 00000114646HL3 MA1541VA01 00000115595HL1 MA1528VA01 00000115655HL3 MA1422VA01 00000114362HL7 PL3243VA01 00000116222HL1 RO1180VA03 00000101672HL4 RU3412VA02 00000105449HL3 RU3412VA02 00000117581HL9 RU8999VA01 00000102617HL8 GPX25909 00000114902HL0 XV114950HL9 00000107206HL5 71006VAS01 00000114949HL1 35054VAS01 00000121381HL8 65020VAS01 00000101147HL7 UZ1027VA01
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.
  • Description du dispositif
    GE Healthcare Optima CL323i || Product Usage: || The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Adresse du fabricant
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA