LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 149…

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1247-2025
• FDA device classification · IDPOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.3010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find LEICA BIOSYSTEMS NUSSLOCH GMBHSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.