Events

Rappel de Device Recall GEHealthcare, Drapes and Sterile Covers

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
    51722
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1730-2009
  • Date de mise en oeuvre de l'événement
    2008-08-29
  • Date de publication de l'événement
    2009-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81090
  • 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
    Protective Cover, Barrier - Product Code MMP
  • Cause
    Ge healthcare has found that the sterile products manufactured by contour fabricators, inc. (cfi) for ge healthcare (gehc) may have sterile seals that could be compromised during the shelf life of the products. this issue could result in the product not maintaining its sterile state.
  • Action
    Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.

Device

Device Recall GEHealthcare, Drapes and Sterile Covers
  • Modèle / numéro de série
    all codes
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.
  • Description du dispositif
    GE Healthcare, Drapes and Sterile Covers || PART NUMBER DESCRIPTION || 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL || 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 || 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS || 00-900493-03 COVER DISPOSABLE X-RAY TUBE || 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) || 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST || 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL || 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 || 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 || 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 || 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL || 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 || 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL || 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 || 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-; || C,9600/7700 || 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 || 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 || 00-901392-01 STRL, COVER, KEYBOARD, 66,68 || 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL || 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK || 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 || 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL || 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 || 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 || 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, || DISPOSABLE BOX 10 PER PKG || 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 || 00-901917-01 STRL, DRAPE, C-ARM, 6800 || 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH || 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 || 00-902752-01 STRL, RUI COVERS 25 COVERS || 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS || 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS || 00-902776-01 STRL, DRAPE, VASCULAR || 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 || 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 || 1003135 STRL, BAG, FLAT PANEL || E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX || E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX || E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX || E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX || E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX || Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. || The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
  • 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