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