Z-1247-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2025
- Initiation Date
- January 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Reason for Recall
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Distribution Pattern
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.
Code Information
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854