Events

Recall of Device Recall Triumph CT and Triumph II CT scanners

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Northridge Tri-Modality Imaging,.

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
    74838
  • Event Risk Class
    Class 2
  • Event Number
    Z-2833-2016
  • Event Initiated Date
    2016-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148565
  • 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, tomography, computed - Product Code JAK
  • Reason
    The firm has determined that several triumph/triumph ii research ct scanners produced by northridge trimodality imaging, inc dba trifoillmaging (or by gamma medica-ideas, inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 cfr 1020.40 (cabinet x-ray standards).
  • Action
    TriFoil lmaging planned action to bring defect into Compliance: 1. All repairs were performed at customer facilities. Customers were contacted by phone to arrange a convenient repair time. 2. TriFoil service engineers installed a collimator on each of the affected cabinet x-ray systems to bring their emission rates into compliance with the emission limit in the performance standard. 3. Full radiation surveys were performed, at maximum exposure settings, to verify each repair was effective. 4. All costs associated with the repair and follow-up testing were paid directly by TriFoil Imaging. CDRH approves the CAP and understands that the CAP was completed on August 29, 2016. For further questions please call (818) 709-2468.

Device

Device Recall Triumph CT and Triumph II CT scanners

Manufacturer

Northridge Tri-Modality Imaging,
  • Manufacturer Address
    Northridge Tri-Modality Imaging,, 9457 de Soto Ave, Chatsworth CA 91311-4920
  • Manufacturer Parent Company (2017)
    Trudell Medical Limited
  • Source
    USFDA