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U.S. Department of Health and Human Services

Class 2 Device Recall Leica MICROSYSTEMS

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 Class 2 Device Recall Leica MICROSYSTEMSsee related information
Date Initiated by FirmNovember 21, 2022
Date PostedDecember 09, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0475-2023
Recall Event ID 91200
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
ProductLeica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Code Information Serial Numbers: 20522001, 20722001, 21221001, 40222001, 40722001, 70722001, 80522002, 110722001, 150422001, 180322001, 211021001, 260722001, 290422001, 300122001, 270522001. ***EXPANSION 09/08/2023, Serial Numbers: 271222001, 100423002, 31022001, 180623001, 71222001, 210523002, 270922002, 120623002, 100123001, 130623001, 290922002, 300922002, 210223001, 220223001, 251122001, 281122001, 20623002, 60922001, 200822001, 40523001, 40523002, 270922001, 61122002, 20423001, 300523002, 190822002, 300922001, 280922001.
FEI Number 3000210133
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
10 Parkway North blvd ste 300
deerfield IL 60089-6622
For Additional Information ContactAndrew Suchomski
224-727-0505
Manufacturer 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 2		Process control
ActionThe 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.
Quantity in Commerce43 units
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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