Z-1247-2025Class II

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software...

Name: Z-1247-2025 Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software...
Creator: Leica Biosystems Nussloch Gmbh
Published: 2025-01-30
License: https://open.fda.gov/license/

Leica Biosystems Nussloch GmbH / initiated 2025-01-30 / Open, Classified / root cause: software

FDA source

LEICA BIOSYSTEMS NUSSLOCH GMBH began a recall of Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 on 2025-01-30. FDA classified it as Class II and gives the reason as "Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1247-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-30
Posted: 2025-02-27
Recalling firm: Leica Biosystems Nussloch GmbH
Product: Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Product code: IDP Microtome, Cryostat
Reason for recall: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2
Distribution: Worldwide - 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.
Product codes and lots: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1247-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-27

Product code IDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)