Events

Rappel de Device Recall MONOPLANE Xray Imaging Systems with Velara Generator

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
    56093
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2448-2010
  • Date de mise en oeuvre de l'événement
    2010-02-04
  • 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
    2011-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92623
  • 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, Angiographic - Product Code IZI
  • Cause
    A lock-up might occur inside the velara generator due to intermittent shorts inside the system. the problem could only resolved by a warm or cold system restart. in exceptional cases the power converters of the kvma unit in the generator are damaged and the system can not be restarted.
  • Action
    On 02/04/2010, Philips Healthcare began sending out the URGENT-Device Correction Notices to their consignees. The firm issued two notifications, one for the Allura Integris and Xper FD10C, FD10F, FD10F/C and FD20 Monoplane X-Ray imaging systems with the Velara Generator. The second notification is for the Allura Integris Xper FD10 and FD20 Biplane X-ray imaging systems with the Velara Generator. This notice informs the consignees that a system locks up during a critical interventional case and it might impose a serious injury to patients. This lock up issue could only be resolved by a warm or cold system restart. A warm restart would take about 90 seconds or a cold restart would take about four minutes, and the device could not be used during this time. If the system does not work after the restart, the consignees should contact the Philips Healthcare Customer Service Representative at 1-800-772-9377 #5 (then follow prompts). A service representative will visit each consignee and conduct a software and hardware upgrade.

Device

Device Recall MONOPLANE Xray Imaging Systems with Velara Generator
  • Modèle / numéro de série
    Each unit is identified with a SITE number:  38358, 101952, 102560, 102564, 102730, 102923, 102948, 103128,  103265, 103275, 103289, 103331, 103380, 103525, 103561, 103562, 103564, 103696, 103729, 103751, 103780, 103781, 103927, 104060, 104075, 104106, 104139, 104149, 104464, 104501, 104512, 104514, 104515, 104536, 104642, 104668, 104670, 104890, 104925, 104927, 104952, 104954, 104955, 104956, 104957, 104958, 105073, 105081, 105082, 105100, 105136, 105137, 105139, 105140, 105153, 105156, 105157, 105186, 105191, 105304, 105343, 105386, 105390, 105402, 105409, 105583, 105598, 105615, 105631, 105655, 105656, 105670, 105674, 105684, 105686, 105742, 105779, 105784, 105866, 105908, 105912, 105917, 105940, 105946, 105947, 105950, 105951, 105952, 105953, 105961, 500004, 500028, 500029, 500038, 500041, 500042, 500052, 504344, 504493, 504636, 504638, 504646, 504659, 504665, 504666, 504730, 504747, 504750, 504769, 504770, 504776, 504789, 504792, 504795, 504797, 504798, 504806, 504807, 504871, 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  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane. || The Monoplane system has one C-arm and it could be mounted on a ceiling or on the floor stand. || The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".
  • 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