Events

Recall of Device Recall Delphi IVantage

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Delphi Medical 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
    35121
  • Event Risk Class
    Class 2
  • Event Number
    Z-1445-06
  • Event Initiated Date
    2006-03-29
  • Event Date Posted
    2006-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45356
  • 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
    Infusion pump - Product Code FRN
  • Reason
    Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
  • Action
    Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.

Device

Device Recall Delphi IVantage
  • Model / Serial
    All serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.
  • Product Description
    Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
  • Manufacturer
    Delphi Medical Systems

Manufacturer

Delphi Medical Systems
  • Manufacturer Address
    Delphi Medical Systems, 5725 Delphi Dr, Troy MI 48098-2815
  • Source
    USFDA