FDA Medical devices recall ·
Leica Biosystems Cryostats Product Name: CM1950 Model recall
- Recall number
- Z-1247-2025
- Date
- (initiated January 30, 2025)
- Company / brand
- Leica Biosystems Nussloch Gmbh
Heidelberger Str. 17-19, Nussloch, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Why was it recalled?
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1247-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.