Recall Z-1247-2025— LEICA BIOSYSTEMS NUSSLOCH GMBH
Class II · Ongoing
Class II FDA medical device recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, initiated 2025-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01. Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue..
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-30
- Firm location
- Nussloch, N/A, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.