Events

Rappel de Device Recall Signa Ovation

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
    56380
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0426-2011
  • Date de mise en oeuvre de l'événement
    2010-08-23
  • Date de publication de l'événement
    2010-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93339
  • 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
    Magnetic resonance diagnostic device - Product Code LNH
  • Cause
    If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
  • Action
    Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.

Device

Device Recall Signa Ovation
  • Modèle / numéro de série
    00000869963YM9 00000145536HM9 00000869962YM1 00000919517YM3 00000919516YM5 00000813945YM3 00000897706YM8 00000813948YM7 00000000798YR9 00000869950YM6 00000813943YM8 00000813958YM6 00000000821YR9 00000837351YM6 00000869949YM8 00000000138YR8 00000837360YM7 00000965778YM4 00000952559YM3 00000000125YR5 00000919523YM1 00000000139YR6 00000000563YR7 00000801209YM8 00000919507YM4 00000869954YM8 00000965828YM7 00000837365YM6 00000801204YM9 00000869953YM0 00000963007YM0 00000837352YM4 00000000812YR8 00000000826YR8 00000000775YR7 00000813947YM9 00000000773YR2 00000919524YM9 00000000827YR6 00000000762YR5 00000000759YR1 00000000130YR5 00000000757YR5 00000869966YM2 00000919519YM9 00000813950YM3 00000000756YR7 00000837359YM9 00000965860YM0 00000000760YR9 00000897700YM1 00000000784YR9 00000000771YR6 00000813960YM2 00000000796YR3 00000000788YR0 00000869956YM3 00000000809YR4 00000144942HM0 00000869961YM3 00000837364YM9 00000000774YR0 00000919526YM4 00000813959YM4 00000952563YM5 00000000786YR4 00000897708YM4 00000000785YR6 00000897716YM7 00000000586YR6 00000837347YM4 00000000768YR2 00000000835YR9 00000000123YR0 00000869947YM2 00000801202YM3 00000801208YM0 00000801206YM4 00000000758YR3 00000000818YR5 00000965775YM0 00000000770YR8 00000000816YR9 00000000564YR5 00000837350YM8 00000000561YR1 00000965780YM0 00000919513YM2 00000813956YM0 00000000825YR0 00000952565YM0 00000000783YR1 00000897699YM5 00000837346YM6 00000869952YM2 00000000772YR4 00000897703YM5 00000919512YM4 00000919521YM5 00000952561YM9 00000919514YMO 00000952547YM8 00000000797YR1 00000813955YM2 00000000776YR5 00000837348YM2 00000813957YM8 00000000781YR5 00000919520YM7 00000919520YM7 00000897714YM2 00000000143YR8 00000801203YM1 00000801199YM1 00000000777YR3 00000000116YR4 00000919509YM0 00000801193YM4 00000184989MR2 00000000117YR2 00000000140YR4 00000869948YM0 00000000767YR4 00000897711YM8 00000000769YR0 00000000141YR2 00000000763YR3 00000897717YM5 00000000766YR6 00000000787YR2 00000869965YM4 00000000565YR2 00000919511YM6 00000813944YM6 00000000794YR8 00000837353YM2 00000000791YR4 00000000823YR5 00000000765YR8 00000000782YR3 00000000824YR3 00000000811YR0 00000919518YM1 00000000761YR7 00000000819YR3 00000965831YM1 00000000836YR7 00000965785YM9 00000965783YM4 00000897698YM7 00000000779YR9 00000952554YM4 00000000828YR4 00000000801YR1 00000000789YR8 00000000803YR7 00000965837YM8 00000919515YM7 00000000832YR6 00000952564YM3 00000952558YM5 00000897715YM9 00000952552YM8 00000000840YR9 00000000790YR6 00000965840YM2 00000000830YR0 00000000800YR3 00000000799YR7 00000919510YM8 00000000838YR3 00000000834YR2 00000952549YM4 00000965767YM7 00000952566YM8 00000000831YR8 00000965836YM0 00000000805YR2 00000000839YR1 00000965768YM5 00000965841YM0 00000897705YM0 00000965774YM3 00000000841YR7 00000952550YM2 00000952548YM6 00000000808YR6 00000000795YR5 00000952555YM1 00000000807YR8 00000965791YM7 00000965789YM1 00000000793YR0 00000000810YR2 00000000780YR7 00000161742HM2 00000000778YR1 00000000837YR5 00000965793YM3 00000000804YR5 00000897712YM6 00000813949YM5
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.
  • Description du dispositif
    Signa Ovation, 0.35T MR Systems (MFO 1-4). || Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.
  • 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