Events

Rappel de BV Endura R2.2 Mobile Xray system

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
    49605
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0141-2011
  • Date de mise en oeuvre de l'événement
    2008-09-05
  • Date de publication de l'événement
    2010-10-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73917
  • 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
    Mobile X-ray system - Product Code JAA
  • Cause
    Reliability of the stand-trolley cable may result in loss of images on the monitor during an examination. this intermittent problem can lead to system lock-up, where no radiation is possible and images are not visible on the monitor.
  • Action
    On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.

Device

BV Endura R2.2 Mobile Xray system
  • Modèle / numéro de série
    127 units are identified with Site Numbers:  544982, 546114, 546792, 546793, 547164, 548598, 548686, 548983, 549986, 549987, 550126, 550127, 550281, 550409, 550838, 550959, 551127, 551274, 551492, 551525, 551589, 551695, 551730, 552376, 552393, 552394, 552398, 552444, 552467, 552468, 552669, 552990, 553098, 553171, 553271, 553860, 553917, 553976, 553989, 554350, 554363, 554497, 554507, 554658, 554779, 555001, 555021, 555243, 555395, 555463, 555517, 555821, 556135, 556171, 556192, 556202, 556215, 556531, 556587, 556608, 556612, 556678, 556862, 556947, 556977, 556979, 557037, 557063, 557147, 557510, 557520, 557590, 558233, 558237, 558613, 558868, 558975, 559070, 559663, 559665, 41416327, 41443832, 41443860, 41445126, 41445430, 41445445, 41445552, 41445931, 41446303, 41566246, 41585083, 41630870, 41658558, 41661638, 41765654, 41796621, 41905206, 41938039, 41955473, 41957114, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42472756, 42551956, 42608281, 42639034, 42824768, 42861875, 42869100, 42880805, 42966787, 43181969, 43209307, 43209310, 43341471, 43453560, 43618928, 43618930, 43721228, 43722015, 45050110, and 45149708.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution.
  • Description du dispositif
    Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".
  • 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