Events

Recall of Device Recall Philips Ingenuity TF PET/CT Imaging Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) 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
    79696
  • Event Risk Class
    Class 2
  • Event Number
    Z-1392-2018
  • Event Initiated Date
    2018-02-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163048
  • 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, tomography, computed, emission - Product Code KPS
  • Reason
    Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. this may prevent an acquisition from proceeding.
  • Action
    On February 15, 2018, the recalling firm notified customers of the recall via letter. The notice stated that to avoid the hazard of performing a rescan or reinjection, all users must be informed not to view studies or access data on the Addonics MSD while a patient is being scanned. If a user is attempting to view information stored on the Addonics MSD and the console appears to be unresponsive, reset power on the Addonics MSD or pull out and reconnect its USB cable. It is recommended that the Addonics USB Mass Storage Device be turned off when not being accessed, and powered on only when data transfer is needed. Following data transfer, the Addonics USB Mass Storage Device should be turned off. Customers were instructed to inform those who need to be aware within their organization or any organization wehre potentially affected devices have been transferred; transfer the notice to other affected organizations; and maintain the recall notice with their system Instructions For Use until the correction is made to the system. Customers were advised that Philips will be providing an updated Mass Storage Device that does not experience the same issue that will be provided at no additional cost to the customer. The Field Correction will be released in Q1 2018. Customers who need further information or support regarding the recall were directed to contact their local Philips representative. Customer Care Solutions Center: 1-800-722-9377.

Device

Device Recall Philips Ingenuity TF PET/CT Imaging Systems
  • Model / Serial
    Serial No: 2090 2072 2077 2079 2086 2091 2093 2085 2076 2071 2078 2081
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
  • Product Description
    Ingenuity TF PET/CT, Model No. 882442 || Product Usage: || The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA