Field Safety Notices about Baby Beets Fetal Doppler

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2008(03)
  • Date
    2008-02-01
  • Event Country
  • Event Source
    HPRA
  • Event Source URL
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The irish medicines board (imb) have been alerted that the ‘baby beets fetal doppler’ is not officially ce marked and therefore may not reach the required standards of safety and quality, as required by the medical device legislation.  this product may have been purchased through the internet.
  • Action
    Check if you have a Baby Beets Fetal Doppler in your possession.   If you have determined that you have this product, you should discontinue use immediately.   If you have any health concerns, please consult your doctor (General Practitioner, Gynaecologist or Obstetrician) for their advice.   If you are selling this product, stop, quarantine the product and contact the IMB immediately.

Device

  • Model / Serial
  • Product Description
    Baby Beets Fetal Doppler
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA