Events

Recall of PLASMA STERILIZER HMTS-40E

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

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
    22961
  • Event Risk Class
    III
  • Event Initiated Date
    2017-04-30
  • 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
    Results of further testing performed on the hmts sterilant agent used in these sterilizers demonstrate that the expiry date of the sterilant can be extended from 1 year to 2 years. as a result the software in the hmts plasma sterilizers must be updated in order to recognize this extended time of expiry. this recall is being initiated in order for scican technicians to perform this software update. there is no safety issue related to this recall and the units can continue to be used.

Device

PLASMA STERILIZER HMTS-40E
  • Model / Serial
    Model Catalog: HMTS-40E (Lot serial: All); Model Catalog: HMTS-30E (Lot serial: All); Model Catalog: HMTS-SES (Lot serial: All); Model Catalog: HMTS-80A (Lot serial: All); Model Catalog: HMTS-80E (Lot serial: All); Model Catalog: HMTS-80 (Lot serial: All); Model Catalog: HMTS-142-R (Lot serial: All); Model Catalog: HMTS-142 (Lot serial: All); Model Catalog: HMTS-142D (Lot serial: All)
  • Product Description
    PLASMA STERILIZER HMTS-40E;PLASMA STERILIZER HMTS-30E;PLASMA STERILIZER - HMTS-SES;PLASMA STERILIZER - HMTS-80A;PLASMA STERILIZER HMTS-80E;PLASMA STERILIZER - HMTS-80;PLASMA STERILIZER - HMTS-142
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Manufacturer Address
    TORONTO
  • Manufacturer Parent Company (2017)
    Scican Ltd
  • Source
    HC