Health product recall

Tissue-Tek AutoSection Automated Microtome (2018-07-11)

Starting date:
July 11, 2018
Posting date:
August 24, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67580

Affected products

Tissue-Tek AutoSection Automated Microtome

Reason

A software bug was discovered in software version 5.89, affecting the emergency stop button not performing as intended. If the Emergency Stop button (ESTOP) is pressed while the microtome is actively cutting, the microtome stops and the chuck homes itself, then resumes cutting. The safety lights flash from red to white to warn users that the chuck is about to move to prevent an accident.

This software bug has been corrected by canceling all cutting actions and placing the microtome in a safe and ready to use position. The latest version of software 5.90a has been released and is ready for installation on your autosection automated microtome now.

Affected products

Tissue-Tek AutoSection Automated Microtome

Lot or serial number

All lots.

Model or catalog number
  • 5000
  • 5010
Companies
Manufacturer

Sakura Finetek USA Inc.

1750 W 214th St

Torrance

90501

California

UNITED STATES