Events

Recall of Device Recall Cleaning probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, 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
    38373
  • Event Risk Class
    Class 3
  • Event Number
    Z-1130-2007
  • Event Initiated Date
    2007-05-18
  • Event Date Posted
    2007-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53502
  • 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
    Cleaning probe for disposable catheters - Product Code LLZ
  • Reason
    Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
  • Action
    Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes.

Device

Device Recall Cleaning probe
  • Model / Serial
    No manufacturing or serial numbers.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada and France.
  • Product Description
    Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA