Events

Rappel de Device Recall Sensor cables

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 OEC Medical Systems, Inc.

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
    58098
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1941-2011
  • Date de mise en oeuvre de l'événement
    2011-02-24
  • Date de publication de l'événement
    2011-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98340
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
  • Action
    GE OEC Medical Systems, Inc sent an Urgent Recall Notice dated March 1, 2011, by certified letter on February 24, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if their Transmitter Sensor Cables or Receiver Sensor Cables have been exposed to any STERRAD sterilizer other than STERRAD 1005, discontinue use of these sterilizers for this product. The Transmitter Sensor Cables should be inspected for signs of material degradation. Further information is available at 800-874-7378.

Device

Device Recall Sensor cables
  • Modèle / numéro de série
    All serial numbers.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI and WV and the countries of Austria, Canada, China, Denmark, England, France, Germany, Hong Kong, India, Ireland, Italy, Japan, San Salvador, Slovakia, Spain, and Switzerland.
  • Description du dispositif
    Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. || Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Adresse du fabricant
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA