Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Reported: March 5, 2025 Initiated: January 30, 2025 #Z-1247-2025
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.
Details
- Recalling Firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Units Affected
- 2
- 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.
- Location
- Nussloch, N/A
Frequently Asked Questions
What product was recalled? ▼
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01. Recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH. Units affected: 2.
Why was this product recalled? ▼
Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2025. Severity: Moderate. Recall number: Z-1247-2025.
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