Events

Recall of HM355S MICROTOME

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

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
    17689
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-23
  • 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
    Occasionally the specimen head will slowly advance on its own as if the advance knob is turned slightly forward. the issue has been identified as a small brass component notmeeting specified tolerances. only a small percentage of units identified by the serial number identified have this issue.

Device

HM355S MICROTOME
  • Model / Serial
    Model Catalog: 36 101 6409 (Lot serial: SERIAL 44478 - 46085)
  • Product Description
    HM355S MICROTOME
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC