Recall Z-2039-2016— Leica Biosystems Richmond Inc.

Name: FDA recall Z-2039-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-02

Class III · Terminated

Class III FDA medical device recall by Leica Biosystems Richmond Inc., initiated 2016-05-02, terminated 2017-12-13. It names one FDA 510(k) clearance: K042542. Product: CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.. Reason: Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated..

Recalling firm: Leica Biosystems Richmond Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-05-02
Terminated: 2017-12-13
Firm location: Richmond, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K042542 — CYTOVISION FOR CEP XYApplied Imaging Corp.·cleared 2005-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

Reason for recall

Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.

Data sourced from openFDA. This site is unofficial and independent of the FDA.