Events

Recall of Device Recall Philips MutliDiagnost Eleva FD

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
    45959
  • Event Risk Class
    Class 2
  • Event Number
    Z-1137-2008
  • Event Initiated Date
    2007-11-29
  • Event Date Posted
    2008-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66580
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Reason
    Delay in imaging: multidiagnost eleva with flat detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. the loss of system availability could occur during an interventional.
  • Action
    On 11/29/07 Philips Medical Systems sent a letter dated 11/28/07 to customers stating that if users perform certain image file housekeeping operations, fluoroscopy cannot be performed and new exposures cannot be acquired until those operations are complete. It also instructs that the unavailability of fluoroscopy and exposure can be avoided by not pressing the "Delete All Images" button until any pending Autopush operation is complete. FCO 70800067 will be issued to service representatives to install new software.

Device

Device Recall Philips MutliDiagnost Eleva FD
  • Model / Serial
    Sysco Software Version 2, release 4.1.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution - CO, MN, NC, NJ and TX.
  • Product Description
    MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips Medical Systems, || Bothell, WA, 98021
  • 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