Events

Rappel de MR Surgical Option for GE 1.5T and 3.0T MRI Systems

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
    72448
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0196-2016
  • Date de publication de l'événement
    2015-10-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141038
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Cause
    Ge became aware of an issue with the table transfer release mechanism of the mr surgical suite option. the issue may prevent patient transfer between the mr and surgical tables.
  • Action
    GE sent an "Urgent Medical Device Correction" letter dated September 23, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You may continue to use the table. Monitor for any issues in releasing the table. If you see this issue, contact a GE Field Engineer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

MR Surgical Option for GE 1.5T and 3.0T MRI Systems
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000304124MR1 904202MR8 00000000UA0116 330344MR750W 00000000UA0117 616267IMRI UA0326 614293MR9 00000307553MR8 415UCBHMR1 00000000UA0296 309655MR750W 00000000UA0396 713792AMR14 00000012228M63 608263MR4IOR N/A 614RMHTMR1 N/A 720848MR4 N/A 309655IMRI 00000299229MR5 AH5824MR01 00000014131M67 MRHM0323 00000018480M64 MR307144MR6 00000021158M61 MRHM0885 00000013254M68 082445160014 00001309FMM07L T4185506 DUMFMI60876024 M347028301 00000021695M62 M4194477 00000305145MR5 UC2547MR01 00001219FMM0H1 EM0105 00001105XF5047 PL2853MR01 00001251FMM044 34368MRS01   UPDATE 11-4-2015:  Mfg Lot or Serial # System ID 2 602406IMR 3 507284NMRV N/A 214820ITABLE N/A 416369MR3T 000000PTST0008 082427040101 000000PTST0007 082427050024 000000PTST0003 CS1020MR01  N/A CS1006MR03 4 YM1733  000000PTST0010 YM3833 000000PTST0006 ZA2169MR01 000000PTST0005 10590MRS01
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of : CA, CO, FL, IL, MI, OH, TX and WI., and to the countries of : AUSTRIA, BRAZIL, FRANCE, GERMANY, JAPAN, POLAND and TURKEY. UPDATE 11-4-2015: Additional states: AZ, MN. Additional countries: Canada, China, Czech Republic, South Africa, and United Kingdom
  • Description du dispositif
    MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. || UPDATE 11-4-2015: Model M0001SS
  • 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