Events

Recall of SMV FX-80 Nuclear Camera

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems.

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
    29756
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-04
  • Event Initiated Date
    2004-07-30
  • Event Date Posted
    2004-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34485
  • 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
    The detector head of a fx-80 nuclear camera may fall from the gantry. three potential causes have been determined. (1) a ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) misalignment of the radial drive assembly. (3) mounting bolts on the radial drive assembly may become loose, fail, or back out.
  • Action
    The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector''s radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become lose, fail, or back out.

Device

SMV FX-80 Nuclear Camera
  • Model / Serial
    00000000000172, 00000000000173, 00000000000188, 00000000000203, 00000000000209, 00000000000214, 00000000000223, 0070090080-103, 0070090080-106, 0070090080-107, 0070090080-112, 0070090080-115, 0070090080-116, 0070090080-123, 0070090080-124, 0070090080-125, 0070090080-126, 0070090080-127, 0070090080-138, 0070090080-141, 0070090080-146, 0070090080-150, 0070090080-152, 0070090080-158, 0070090080-161, 0070090080-162, 0070090080-163, 0070090080-164, 0070090080-165, 0070090080-167, 0070090080-168, 0070090080-170, 0070090080-172, 0070090080-173, 0070090080-179, 0070090080-180, 0070090080-188, 0070090080-203, 0070090080-209, 0070090080-96, 0070090080-P298
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Inside the US. Manufactured and distributed from 1993 - 2000.
  • Product Description
    SMV FX-80 Nuclear Camera
  • Manufacturer
    General Electric Med Systems

Manufacturer

General Electric Med Systems
  • Manufacturer Address
    General Electric Med Systems, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA