Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw
Summary
The FDA issued a Class II for Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Numb by LEICA BIOSYSTEMS NUSSLOCH GMBH. Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue..
Details
Source
Device Recall
External ID
Z-1247-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
Product Description
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Lot/Code Info: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
Quantity Affected: 2
Reason for Recall
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-30
Company
Nussloch, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LEICA BIOSYSTEMS NUSSLOCH GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LEICA BIOSYSTEMS NUSSLOCH GMBH have FDA actions?
LEICA BIOSYSTEMS NUSSLOCH GMBH has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1247-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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