Events

Rappel de Device Recall GE Discover MR450 (narrow bore)

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 Healthcare, 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
    76378
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1188-2017
  • Date de mise en oeuvre de l'événement
    2017-01-20
  • Date de publication de l'événement
    2017-02-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153004
  • 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
    Potential safety issue with the patient bore heating on the discovery mr450 narrow bore 1.5t mri. in the event of a rf component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. if this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter GEHC Ref# 60913 Dated January 20, 2017. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Discover MR450 (narrow bore)
  • Modèle / numéro de série
    Mfg. Lot or Serial # System ID 00001106XF509E 209225VC450 00001106XF50A6 858939MR4 000000000R7216 858939MR3 000000000R2645 202715MR2 00000842BD50C2 202476MR1 000000000R7025 217383CMR5 00000944BD6155 MR129036 101BD66B6 573884MRI 00000945BD6182 417COXMR1 000000000R2768 HSSFMR450 00001009BD65C1 HSS75MR450 00000944BD6166 803434MRI 00000298722MR0 803434MR2 00000300039MR5 832522MR2 Not Available 713566SMITH1 1106xf508e 713566SMITH3 00000296429MR4 281364MR2 00000833BD4AE7 920830MR450 00000933BD5DF8 304256MR2 00000294451MR0 030020MR03 000000000R7320 403541MR1 00000944BD616B 403955MR1 000000000R7149 250727MR2 Not Available 905522MR2 00001101XF5028 514281MR450 00000297813MR8 CS1006MR04 00000294548MR3 DK1083MR06 00000294397MR5 FI1128MR01 00000295485MR7 FI1052MR01 00000296032MR6 A2032112 00000295847MR8 M4182438 00000293919MR7 M206565701 00000294575MR6 M40330108 00000298332MR8 RMUE01MR04 0002001-0917-3 A5127236 00000304354MR4 A5808528 00000296820MR4 A5624132 00000297807MR0 D5354206 00000293603MR7 RTD0127 DUMFMI60898001 NO1017MR03 00000297987MR0 NO1009MR02 00000296493MR0 PL1539MR01 00000300882MR8 SA1058MR02 00000296613MR3 SA1011MR03 00000299452MR3 CPZ43620 00000303993MR0 M001MR01 00000293000MR6 A010MR06 00000293920MR5 N002MR02 00000303992MR2 541010MR03 00000300849MR7 0853270113 00000292973MR5 00242MRS02 00000293206MR9 70001MRS09 00000298041MR5 05217MRS02 00000293642MR5 10448MRS02 00000293724MR1 10050MRS03 00000299340MR0 00010MRS01 00000295709MR0 00200MRS04 00000294967MR5 00100MRS01 00000296514MR3 00105MRS02 00000300689MR7 2948529MR
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay.
  • Description du dispositif
    Discovery MR450 || The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps. and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate. blood vessels, and musculoskeletal regions of the body.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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