FDA Medical Device Recalls (openFDA)
LEICA BIOSYSTEMS NUSSLOCH GMBH: Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Recall number
- Z-1247-2025
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Status
- Open, Classified
- Initiated
- 2025-01-30
- Posted
- 2025-02-27
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IDP
- Firm FEI
- 3002179321
- Firm city
- Nussloch
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28