Leica CM1950 Cryostat (Leica) – firmware data loss (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Brand
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany
Lot Codes / Batch Numbers
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
Products Sold
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany is recalling Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Softwa due to Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026