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Aperio eSlide Manager (2016-04-04)
- Starting date:
- April 4, 2016
- Posting date:
- May 16, 2016
- 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-58346
Affected products
- Aperio eSlide Manager
Reason
It is possible to have incorrect label information displayed when viewing multiple Hamamatsu.ndpi (Brightfield) and .ndpis (Fluorescent) images with ImageScope software. Slides which do not use the .ndpi file format are not affected
Affected products
A.Aperio eSlide Manager
Lot or serial number
Software Version 12.2.1
Software Version 12.2.2
Software Version 12.3
Model or catalog number
23ESLIDEMAN-PERP1-IVD
23ESLIDEMGR1-IVD
23S+2-IVD
Companies
- Manufacturer
-
LEICA BIOSYSTEMS IMAGING, INC.
1360 PARK CENTER DRIVE
VISTA
92081
California
UNITED STATES