Events

Recall of Device Recall Innocor pulmonary function test device

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

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
    74649
  • Event Risk Class
    Class 2
  • Event Number
    Z-2769-2016
  • Event Initiated Date
    2016-05-13
  • Event Date Posted
    2016-09-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148100
  • 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
    Calculator, pulmonary function data - Product Code BZC
  • Reason
    The purpose of the recall is to replace data transmission cable (usb-cable) connecting the lnnocor device with an external computer. the replacement usb cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. the replacement is intended to prevent risk of electric shock.
  • Action
    Recall notifications described the issue and actions to be taken by the firm. The notice also stated that replacement costs would be carried by Innovision ApS. Acknowledgment of the notice can be made by contacting service manager Knud Pedersen at kp@innovision.dk or (+45) 65 95 91 00) to schedule the service activity and to answer any questions.

Device

Device Recall Innocor pulmonary function test device
  • Model / Serial
    Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.
  • Product Description
    Innocor Cardiopulmonary Exercise and Lung Function Testing System || Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
  • Manufacturer
    Innovision A/S

Manufacturer

Innovision A/S
  • Manufacturer Address
    Innovision A/S, Skovvaenget 2, Glamsbjerg Denmark
  • Source
    USFDA