Events

Recall of Device Recall i.v. Station, i.v. Station ONCO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HEALTH ROBOTICS S.R.L..

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
    76102
  • Event Risk Class
    Class 2
  • Event Number
    Z-0989-2017
  • Event Initiated Date
    2016-11-23
  • Event Date Posted
    2017-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152440
  • 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/device, pharmacy compounding - Product Code NEP
  • Reason
    The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final iv bag preparations.
  • Action
    Omincell mailed an Urgent Medical Device Field Correction Notification letter to affected customers on 11/21/2016. The letter provided information of the event and instructions on how to continue operating the device to prevent risks. The issue will be corrected with a software update.

Device

Device Recall i.v. Station, i.v. Station ONCO
  • Model / Serial
    All serial numbers are affected.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Shipped throughout United States.
  • Product Description
    i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System || Device Listing Number E454448
  • Manufacturer
    HEALTH ROBOTICS S.R.L.

Manufacturer

HEALTH ROBOTICS S.R.L.
  • Manufacturer Address
    HEALTH ROBOTICS S.R.L., Via Sebastian Altmann 9 A, 39100, Bolzano Italy
  • Manufacturer Parent Company (2017)
    Aesynt Holding Coöperatief U.A.
  • Source
    USFDA