Events

Rappel de Device Recall Multi Diagnost Eleva

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
    44910
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0912-2007
  • Date de mise en oeuvre de l'événement
    2007-07-23
  • Date de publication de l'événement
    2007-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64518
  • 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
    X-Ray System - Product Code IZI
  • Cause
    Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
  • Action
    On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.

Device

Device Recall Multi Diagnost Eleva
  • Modèle / numéro de série
    Site numbers 103056, 104136, 521113 102666, 104083, 104530, 105193, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506155, 506236, 506247, 519574, 532087, 532140, 532151, 532213, 532703, 533312, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 538440, 539457, 539598, 539990, 540252, 541263, 541474
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Units were distributed to 1543 hospitals and medical centers throughout the US. No international distribution from this firm.
  • Description du dispositif
    Philips Multi Diagnost Eleva
  • 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