Events

Recall of ASP6025 TISSUE PROCESSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS NUSSLOCH GMBH.

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
    106920
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-06
  • 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
    The affected devices have incorrect labelling with regard to the specified voltage for the alarm connectors on the rear side of the instrument. the current incorrect labels specify 125va.C as maximum voltage. it has been identified that if someone connects such 125va.C to the 6.3mm stereo jack there would be hazardous voltage accessible on the plug which could lead in the worst case to a serious electrical incident. in addition the current specification in the instruction for use (ifu) has an incorrect labelling with regard to the specified voltage for the alarm connectors. the translated ifu's and the "online help" of the instruments also have an incorrect labelling with regard to the specified voltage of the alarm connectors.

Device

ASP6025 TISSUE PROCESSOR
  • Model / Serial
    Model Catalog: ASP6025 (Lot serial: 314); Model Catalog: ASP6025 (Lot serial: 712); Model Catalog: ASP6025 (Lot serial: 778); Model Catalog: ASP6025 (Lot serial: 594); Model Catalog: ASP6025 (Lot serial: 538); Model Catalog: ASP6025 (Lot serial: 448); Model Catalog: ASP6025 (Lot serial: 316)
  • Product Description
    Leica ASP6025 Tissue Processor
  • Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH

Manufacturer

LEICA BIOSYSTEMS NUSSLOCH GMBH