Events

Rappel de BV Endura Rel 2

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 Philips Medical Systems North America Co. Phillips.

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
    50066
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2464-2010
  • Date de mise en oeuvre de l'événement
    2008-09-10
  • Date de publication de l'événement
    2010-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74614
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Cause
    The c-arm rotation brake does not always function properly, and may not hold the c-arm position if the c-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. unwanted c-arm movement may cause the c-arm to collide with a patient. the brakes function properly if the c-arm is rotated to its maximum positions.
  • Action
    Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377

Device

BV Endura Rel 2
  • Modèle / numéro de série
    Devices are identified with Site Numbers: 548598, 550838, 551589, 551695, 552444, 552467, 552468, 552669, 553171, 553860, 553917, 553976, 553989, 554350, 554497, 555001, 555021, 555243, 555395, 555463, 555517, 556135, 556171, 556531, 556587, 556608, 556612, 556678, 556862, 556977, 556979, 557037, 557063, 557590, 558233, 558237, 558613, 558975, 559070, 559663, 559665, 41416327, 41443860, 41445126, 41445430, 41445445, 41445552, 41566246, 41585083, 41658558, 41765654, 41796621, 41905206, 41938039, 41955473, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42608281, 42639034, 42824768, 42861875, 42869100, 42869163, 42880805, 42966787, and 42975222.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: Throughout the US.
  • Description du dispositif
    Philips BV Endura Mobile X-Ray system with the extended rotation option.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA