Brand Name: Leica Biosystems Cryostats Product Name: CM1950… — Class II medical device recall Z-1247-2025
Ongoing recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, reported 2025-03-05, distributed nationwide. Firm became aware of software issues related to most recent firmware update which could result in loss of pati
| Recall number | Z-1247-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEICA BIOSYSTEMS NUSSLOCH GMBH, Nussloch, N/A, Germany |
| Recall initiated | 2025-01-30 |
| Classified | 2025-02-27 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CN, DE, ES, FR, GB, HK, IE, IT, JP, NL, NO, PL, SG |
| Quantity | 2 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04049188139030 |
| Serial numbers | 12835, 12854 |
| Model numbers | 1491950C4US |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1247-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.