Recall Z-1247-2025 ยท IDP Microtome, Cryostat
LEICA BIOSYSTEMS NUSSLOCH GMBH
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
| Date | Feb 27, 2025 (initiated Jan 30, 2025) |
| Status | Open, Classified |
| Reason | Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.