Events

Rappel de Device Recall CareVue Chart

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 Healthcare Inc..

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
    51982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1436-2009
  • Date de mise en oeuvre de l'événement
    2009-05-05
  • Date de publication de l'événement
    2009-05-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81825
  • 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
    Medical Cathode-Ray Tube Display - Product Code DXJ
  • Cause
    Software: a software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period.
  • Action
    Philips Medical notified accounts by letter on 5/6/09 the Urgent - Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within CareVue Chart to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist. Philips is currently developing a correction that will be available at no additional charge. A Philips representative will notify customers when the software correction becomes available. If further assistance is needed, customers are to contact the Philips Customer Care Center at 1-800-722-9377.

Device

Device Recall CareVue Chart
  • Modèle / numéro de série
    Serial Numbers: 4621A00101, 4621A00102, 4621A00103, 4621A00104, 4621A00105, 4621A00106, 4621A00107, 4621A00108, 4621A00109, 4621A00110, 4621A00111, 4621A00112, 4621A00113, 4621A00114, 4621A00115, 4621A00116, 4621A00117, 4621A00118, 4621A00119, 4621A00120, 4621A00121, 4621A00122, 4621A00123, 4621A00124, 4621A00125, 4621A00126, 4621A00127, 4621A00128, 4621A00129, 4621A00130, 4621A00131, 4621A00132, 4621A00133, 4621A00134, 4621A00135, 4621A00136, 4621A00137, 4621A00138, 4621A00139, 4621A00140, 4621A00141, 4621A00142, 4621A00143, 4621A00144, 4621A00145, 4621A00146, 4621A00147, 4621A00148, 4621A00149, 4621A00150, 4621A00151, 4621A00152, 4621A00153, 4621A00154, 4621A00155, 4621A00156, 4621A00157, 4621A00158, 4621A00159, 4621A00160, 4621A00161, 4621A00162, 4621A00163, 4621A00164, 4621A00165, 4621A00166, 4621A00167, 4621A00168, 4621A00169, 4621A00170, 4621A00171, 4621A00172, 4621A00193, 4621A00194, 4621A00195, 4621A00196, 4621A00197, 4621A00198, 4621A00199, 4621A00200, 4621A00201, 4621A00202, 4621A00203, 4621A00204, 4621A00205, 4621A00206, 4621A00207, 4621A00208, 4621A00209, 4621A00210, 4621A00211, 4621A00213, 4621A00214, 4621A00217, 4621A00218, 4621A00219, 4621A00220, 4621A00221, 4621A00222, 4621A00223, and  4621A00224.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom.
  • Description du dispositif
    CareVue Chart Release C.O || Part Number: 862246 || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA