Events

Recall of Device Recall Juno

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
    63868
  • Event Risk Class
    Class 2
  • Event Number
    Z-0702-2013
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114934
  • 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
    X-ray controls - fluoroscopic - Product Code RCA
  • Reason
    Values of fluoroscopy time, air kerma rate and cumulated air kerma may not be displayed "at the fluoroscopist's working position" as per 21 cfr 1003.21.
  • Action
    Philips Medical issued a notification by letter dated December 13, 2012. via Certified Mail to affected customer. The letter identified the affected product, problem and actions to be taken. Philips will contact affected customers to schedule an upgrade of the equipment . For questions or support concerning this issue, please contact Dominic Siewko at 978-659-7936.

Device

Device Recall Juno
  • Model / Serial
    Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040  :
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
  • Product Description
    Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose || Model: 70920 || Product Usage: || Universal R/F, general use
  • 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