Events

Recall of Device Recall MultiDiagnost 4

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

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
    25406
  • Event Risk Class
    Class 2
  • Event Number
    Z-0586-03
  • Event Initiated Date
    2003-01-10
  • Event Date Posted
    2003-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25769
  • 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, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    Internal short circuit - may allow for stand and table to move spontaneously in upward or downward movement.
  • Action
    The firm issued a letter dated January 10, 2003 to their customers advising of the problem and that a respresentative would be contacting customers to arrange a time to visit to install new interface board. This is being conducted under FCO 70800007

Device

Device Recall MultiDiagnost 4
  • Model / Serial
    Serial numbers include (but are not limited to): 4584520996, 4594911196, 4595090397, 4595290697, 4594871196, 4594841196, 4595130197, 4615641197, 4595240797, 459500197, 4615511097, 4615581097, 4584570996, 4615320897, 459516497, 4595070197, 4584320996, 4584721096, 4615661197, 4594980197  Part numbers: 9896 000 58511, 9896 000 58512, 9896 000 58521, 9896 000 58522
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed to 22 hospitals/medical centers located in CA, FL, IA, IL, IN, KY, MN, MO, NC, ND, NY, OH, SC, TN, TX, VA, and WV.
  • Product Description
    MultiDiagnost 4 - x-ray system, multi functional/universal system for general use.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA