Events

Recall of Device Recall ArchiWin Colour

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Esaote Biomedica S.P.A..

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
    27980
  • Event Risk Class
    Class 2
  • Event Number
    Z-0534-04
  • Event Initiated Date
    2003-12-23
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31235
  • 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
    Electrocardiograph - Product Code DPS
  • Reason
    If certain keys on the keyboard are pressed during rest ecg procedure, the ecg data may be assigned to the wrong patient.
  • Action
    A recall letter dated December 23, 2003 was sent to distributors asking them for contact information for affected customers. Esaote will the provide the user customers with an addendum to the users manual until a software upgrade becomes available and is installed.

Device

Device Recall ArchiWin Colour
  • Model / Serial
    Serial number 149.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Florida, Indiana, Kentucky, Brazil, Colombia and Japan.
  • Product Description
    Esaote brand ArchiWin Colour ECG System; part 9704325000.
  • Manufacturer
    Esaote Biomedica S.P.A.

Manufacturer

Esaote Biomedica S.P.A.
  • Manufacturer Address
    Esaote Biomedica S.P.A., c/o The Anson Group, 7992 Castleway Drive, Indianapolis IN 46250-1943
  • Source
    USFDA