Events

Recall of Bio Cal temperature controllers

According to Health Andorra, this recall involved a device in Andorra that was produced by Bio-Cal.

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
    ARS/2018/13647
  • Date
    2018-02-16
  • Event Country
    Andorra
  • Event Source
    HA
  • Event Source URL
    https://www.salut.ad/alertes/alertes.php?_pagi_pg=16&data1=&data2=&tipus=PRODUCTES%20SANITARIS%20-%20Retirada&titol=
  • Notes / Alerts
    Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 recall data from the U.S. and Andorra.
  • Extra notes in the data

Device

Bio Cal temperature controllers
  • Model / Serial
  • Product Description
    Warning bio-cal temperature controller
  • Manufacturer
    Bio-Cal

Manufacturer

Bio-Cal
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HA