Leica Biosystems Cryostats CM1950 recall — FDA Z-1247-2025
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Overview of recall records associated with LEICA BIOSYSTEMS NUSSLOCH GMBH, including dates, categories and classifications where available.
Classification mix: Class II: 10.
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially…
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover…
This page summarizes recall records in which the official source identifies LEICA BIOSYSTEMS NUSSLOCH GMBH as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.