Recall Z-0476-2023

Reason for recall

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDA-determined cause: Process control

Action taken

The firm issued an URGENT FIELD SAFETY NOTICE to its consignees by email on 11/21/2022. The notice explained the issue and stated that a Leica Microsystems representative would be contacting each facility to arrange an update to the the affected devices and advised the following: Consignees can continue to use the system pending the field update; Ensure that all users of the affected microscope are aware of the Safety notes as described in section 3 of the respective user manual; Like any other instrument in the operating theater, the system may fail and Leica Microsystem (Schweiz) AG recommends that a backup system be kept available during the operation; Check before the operation : Connect the power cable. + Switch on the microscope. UPDATE 09/12/2023: Recall was expanded, and customers were sent the notification on about 09/11/2023. Each consignee is requested to acknowledge receipt of the Field Safety Notice letter outlining the potential manufacturing defect, perform an initial inspection, indicate the results of the initial inspection, and provide contact information for further Leica Microsystems Representative verification of conformity/defect.