Events

Rappel de Intera 1.5T and 1.5T Achieva MRI systems

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
    49594
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2461-2010
  • 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
    2010-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73890
  • 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
    Coil, magnetic resonance, specialty - Product Code MOS
  • Cause
    The cables of the coil may become too hot and cause burns when placed too close to the patient. while using the 1.5t sense xl torso coil, unwanted radiofrequencies (rf) interaction with the patient can occur. especially in combination with high sar levels and when the rf cables of the coil are too close to the patient, this rf interaction has resulted in rf burns to patients.
  • Action
    Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers.. The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #3, #1 and reference "FCO 78100242 - PATIENT CABLE SLEEVE FOR 1.5T SENSE XL TORSO COIL".

Device

Intera 1.5T and 1.5T Achieva MRI systems
  • Modèle / numéro de série
    Devices are identified as Site numbers: 544006, 537871, 534961, 544704, 545154, 545236, 545219, 545943, 546637, 545879, 545914, 543286, 547585, 548729, 550876, 553379, 550044, 554797, 41443789, 555412, 41444993, 41445232, 556803, 557348, 557344, 557513, 557179, 557644, 557560, 551656, 558845, 41446147, 552550, 552516, 555787, 41445636, 41455922, 83325, 558369, 86968, 101408, 101877, 102110, 102353, 102004, 104343, and 41455948.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: Throughout USA. No distribution to foreign consignees.
  • Description du dispositif
    Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
  • 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