Events

Recall of THERMOVAL RAPID

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Paul Hartmann laboratories.

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
  • Date
    2004-04-19
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-tous-les-lots-du-dispositif-medical-thermoval-rapid-des-laboratoires-paul-hartmann
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    In agreement with Afssaps, the Paul Hartmann laboratories decided to suspend the marketing and to withdraw from the market all batches of the medical device THERMOVAL RAPID, electronic thermometer (ref 925033). Indeed, when used in the vicinity of electrical devices emitting electrostatic fields, the microprocessor of the thermometer may be damaged, which may result in the display of erroneous temperatures (too low temperatures). The 33 pharmacies receiving the batches were informed directly of this recall (see attached letter (19/04/2004) (67 KB)).

Device

THERMOVAL RAPID

Manufacturer

Paul Hartmann laboratories
  • Source
    LAANSM