Events

Recall of Device Recall Philips MultiDiagnost Eleva II Software Version R4.1

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

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
    61267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1196-2012
  • Event Initiated Date
    2012-02-24
  • Event Date Posted
    2012-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107690
  • 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
    Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
  • Action
    Philips Healthcare issued Urgent Field Safety Notices dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. No action is necessary by the customer/user. A mandatory Field Safety Correction (FCO) Action will be issued to solve the problem. The FCO will consists of a Software update. For further support customers were instructed to contact their Phillips representative. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips MultiDiagnost Eleva II Software Version R4.1
  • Model / Serial
    Software Version R4.1.x S/N: 284 290 291 293 294 295 296 297 298 299 303 305 306 307 308 309 310 312 314 315 316 317 318 327 329 338 346 349 350 352 353 354 354 355 358 362 365 366 367
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the following countries: Canada, Australia Austria Belgium Bahrain Czech Republic Denmark Estonia France Finland Germany Hong Kong Israel Italy Latvia Luxemburg Malaysia Mexico Netherlands New Zealand Norway Russian Fed SAUDI ARABIA Serbia Slovakia Solvenia South Africa Spain Switzerland Sweden Syria Thailand Turkey United Kingdom
  • Product Description
    Philips MultiDiagnost Eleva II Software Version R4.1.x || Model: 708032 || This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Manufacturer Address
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA