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U.S. Department of Health and Human Services

Class 2 Device Recall Leica Biosystems Cryostats

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 Class 2 Device Recall Leica Biosystems Cryostatssee related information
Date Initiated by FirmJanuary 30, 2025
Date PostedFebruary 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1247-2025
Recall Event ID 96220
Product Classification Microtome, cryostat - Product Code IDP
ProductBrand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Code Information Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
Recalling Firm/
Manufacturer		 LEICA BIOSYSTEMS NUSSLOCH GMBH
Heidelberger Str. 17-19
Nussloch Germany
For Additional Information ContactMargaret Walczak
815-2002717
Manufacturer Reason
for Recall		Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn January 30, 2025, the firm notified customers through Email of the recall. Customers were provided with immediate actions to take to mitigate the risk of damaging the tissue sample. Among the firm's recommendations was to have a backup instrument if available. The firm's Service organization will contact customers in the coming weeks to organize the upgrade of affected instruments.
Quantity in Commerce2
DistributionWorldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.
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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