Events

Recall of Device Recall ACHIEVA 3.0T and Panorama 1T

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
    57351
  • Event Risk Class
    Class 2
  • Event Number
    Z-0794-2011
  • Event Initiated Date
    2009-05-12
  • Event Date Posted
    2010-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95927
  • 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
    Nuclear Magnetic Resonance Imaging System - Product Code LNH
  • Reason
    The accessory cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
  • Action
    On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site. The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then follow prompts) and reference FCO 78100296 with any communication.

Device

Device Recall ACHIEVA 3.0T and Panorama 1T
  • Model / Serial
    Site numbers: 505048, 505705, and 41445594.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- IL, MI, and MD.
  • Product Description
    Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. || Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.
  • 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