Leica Biosystems Cryostat CM1950 Firmware Update May Cause Tissue Loss
A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a serious potential hazard (loss of patient tissue). No illnesses or injuries reported; the hazard is theoretical. Per the rubric, potential risk-of-harm without reported injury scores as 'High' (3).
Plain-English summary
The Leica Biosystems CM1950 cryostat (model 1491950C4US, firmware V3.01) is being recalled due to software issues related to a recent firmware update.
The software malfunction could result in loss of patient tissue. Two units with serial numbers 12835 and 12854 are affected. The devices have been distributed worldwide, including in the United States (Idaho and Ohio) and internationally in France, Australia, Belgium, China, Germany, Spain, the United Kingdom, Hong Kong, Ireland, Italy, Japan, the Netherlands, Norway, Poland, and Singapore.
The recalled product
- Product
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Hazard
- software-malfunction
- tissue-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835
- 12854
Distribution
Distributed nationwide across the United States.
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