Events

Recall of Device Recall CareVue Chart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51982
  • Event Risk Class
    Class 2
  • Event Number
    Z-1436-2009
  • Event Initiated Date
    2009-05-05
  • Event Date Posted
    2009-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81825
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Cathode-Ray Tube Display - Product Code DXJ
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA