Events

Recall of Device Recall COROMETIRICS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Information Technologies.

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
    26452
  • Event Risk Class
    Class 2
  • Event Number
    Z-1291-03
  • Event Initiated Date
    2003-05-21
  • Event Date Posted
    2003-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27708
  • 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, Monitoring, Perinatal - Product Code HGM
  • Reason
    The 2120 main board on device lacks required external safety 'watchdog' circuit.
  • Action
    The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.

Device

Device Recall COROMETIRICS
  • Model / Serial
    All serial numbers are involved.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The monitors were distributed to 8 hospitals in SC, WI, CA, MN, TX, MD and NV, as well as two hospitals in France.
  • Product Description
    GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies
  • Manufacturer Address
    GE Medical Systems Information Technologies, 4502 Woodland Corporate Blvd., Tampa FL 33614
  • Source
    USFDA