Events

Recall of Device Recall CDLCAM, Onepass Nuclear Medicine Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GVI Technology Partners.

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
    28161
  • Event Risk Class
    Class 3
  • Event Number
    Z-0527-04
  • Event Initiated Date
    2004-01-16
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31299
  • 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
    Camera, Scintillation (Gamma) - Product Code IYX
  • Reason
    Due to limitations in the operating software, the acquired scan may not be processed properly.
  • Action
    The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.

Device

Device Recall CDLCAM, Onepass Nuclear Medicine Imaging System
  • Model / Serial
    S/Ns: 100 thur 105, and 107 thru 116.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    One Single customer.
  • Product Description
    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
  • Manufacturer
    GVI Technology Partners

Manufacturer

GVI Technology Partners
  • Manufacturer Address
    GVI Technology Partners, 1470 Enterprise Pkwy, Twinsburg OH 44087-2242
  • Source
    USFDA