Events

Recall of HAND-HELD SPOT PROBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SISTEMI SRL.

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
    53510
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    S.I.S.T.E.M.I srl are notifying their customers that they do not hold a device license for the seqex medical devices.

Device

HAND-HELD SPOT PROBE
  • Model / Serial
    Model Catalog: HAND-HELD SPOT (Lot serial: CONTACT MANUFACTURER); Model Catalog: INTENSIVE PAD (Lot serial: CONTACT MANUFACTURER); Model Catalog: SMART (Lot serial: CONTACT MANUFACTURER); Model Catalog: FIELD INCREASERS (Lot serial: CONTACT MANUFACTURER); Model Catalog: MED (Lot serial: CONTACT MANUFACTURER); Model Catalog: FAM (Lot serial: CONTACT MANUFACTURER); Model Catalog: HC (Lot serial: CONTACT MANUFACTURER)
  • Product Description
    HAND-HELD SPOT PROBE;PRO INTENSIVE APPLICATOR;SMART SEQEX;FIELD ENHANCEMENT SET;SEQEX MED;SEQEX FAM;SEQEX HC;HOME UNIT INTENSIVE APPLICATOR
  • Manufacturer
    SISTEMI SRL

Manufacturer

SISTEMI SRL
  • Manufacturer Address
    TRENTO
  • Source
    HC