Events

Recall of Device Recall Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

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
    57068
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-2011
  • Event Initiated Date
    2009-03-06
  • Event Date Posted
    2011-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95612
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    Images from two different patients may be combined in one patient folder in the digital image (di) or may be combined as one (printed) image. it is possible that an image of a previous patient registered in the di will be overwritten with an image of a later patient.
  • Action
    On March 6, 2009, Philips sent an "URGENT-Device Correction Easy Diagnost Eleva, MultiDiagnost Eleva, and OmniDiagnost Eleva with DI Rel. 2 systems notification" to their consignees/customers. The consignees/customers are advised that before diagnosing images, always check the stored (Digital Image, Viewform or PACS) or printed images to ensure that these represent the data and images captured from the examination of the respective patient. Do not use images if they do not represent the patient that was examined. Consignees will be contacted by Philips to schedule a software upgrade of their units. The consignees can contact Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference "FCO 70800070" with any questions about this recall.

Device

Device Recall Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system
  • Model / Serial
    Site Numbers:   533530, 535118, 535257, 535924, 539106, 540860, 541490, 547017, 547142, 547348, 549798, 550258, and 553235.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AZ, CA, CO, CT, DE, FL, GA, HI, ID, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WY.
  • Product Description
    Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. || The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA