Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
This recall is currently active, issued February 27, 2025. It was issued by Leica Biosystems Nussloch Gmbh Heidelberger Str. 17-19 Nussloch Germany.
- Recall Initiated
- January 30, 2025
- Posted
- February 27, 2025
- Recall Number
- Z-1247-2025
- Quantity
- 2
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
Root Cause
Under Investigation by firm
Action Taken
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.