Recall of Device Recall Leica Biosystems Richmond Inc

Recall

74245

Class 3

Z-2039-2016

2016-05-02

Terminated

United States

2017-12-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146970

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.

Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 2, 2016. According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. The Medical Device Field Correction letter describes the issues identified with the CytoVision Image Analysis and Capture System and the Windows 7 operating system. The letter provided the customer with actions they are required to take which include the following: 1) whether they have a properly activated Windows 7 operating system. 2) If they do not have a properly activated operating system they should to contact Leica Technical Support for additional information and to request a service appointment for correction to their system. For USA customers, they ask that they call 18005374669. International customers are asked to go to http://www.leicabiosystems.com/contactus/contactusonline/ and then choose your country. 3) Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to RichRA@leicamicrosystems.com or faxing it back to us at 18472363800. Service personnel will be sent to the affected customer locations to replace the hard drives of the affected systems.