FDA Device recall Z-1247-2025
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 by Leica Biosystems Nussloch, citing firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1247-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-30 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Leica Biosystems Nussloch |
| Distribution | US |
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.
Identifiers
| code_info | Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1247-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.