Cytovision System for Karyotyping (2016-04-28)

Starting date:

April 28, 2016

Posting date:

July 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59586

• Reason
• Affected products

Affected products

1. K/F STATION
2. STATION UPGRADE
3. CYTOVISION STATION XP TO WIN7 UPGRADE

Reason

Leica Biosystems Richmond Inc. has identified a potential error on the CytoVision image analysis and capture systems. An issue during the manufacturing process might have caused these systems to have an improperly activated Windows 7 operating system, even though a valid Windows 7 license was associated with each manufacturing system. It has been determined these systems cannot be re-activated using standard windows licensing procedures and a check of the systems to confirm windows is properly activated is required.

Affected products