Events

Rappel de Rapid Strand Rx

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 Medi-Physics Inc. dba GE Healthcare.

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
    60005
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0266-2012
  • Date de mise en oeuvre de l'événement
    2011-09-20
  • Date de publication de l'événement
    2011-11-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104223
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • Cause
    There is a potential brachytherapy over or under dose with the rapid strand rx kit that may impact patient therapy.
  • Action
    GE Healthcare/Oncura sent a "Urgent Medical Device Correction" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have. Please call if you have any further questions (847) 398-8400 and 011-44-1494-737251 (Amersham, United Kingdom, GMT)

Device

Rapid Strand Rx
  • Modèle / numéro de série
    product identifier: I125RSRX, Oncura order numbers 85342, 85778, 85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070, 88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom
  • Description du dispositif
    Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. || RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.
  • Manufacturer
    Medi-Physics Inc. dba GE Healthcare

Manufacturer

Medi-Physics Inc. dba GE Healthcare
  • Adresse du fabricant
    Medi-Physics Inc. dba GE Healthcare, 3350 N Ridge Ave, Arlington Heights IL 60004-1412
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA