Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
LEICA BIOSYSTEMS NUSSLOCH GMBH · Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Open FDA's page for this record- Cfres ID
- 212369
- Product res number
- Z-1247-2025
- Event date initiated
- 2025-01-30
- Event date posted
- 2025-02-27
- Recall status
- Open, Classified
- Res event number
- 96220
- Product code
- IDP
- Product description
- Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- Code info
- Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854
- Firm FEI number
- 3002179321
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Address 1
- Heidelberger Str. 17-19 17-19 heidelberger str.
- City
- Nussloch
- Country
- Germany
- Additional info contact
- Margaret Walczak 815-2002717
- Reason for recall
- Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
- Root cause description
- Under Investigation by firm
- Product quantity
- 2
- 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.
- Distribution pattern
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.
- Harmonized identifiers (openFDA)
- Device name
- Microtome, Cryostat
- Medical specialty description
- Pathology
- Regulation number
- 864.3010
- Device class
- 1
- Registration number
- 3021013124, 3014680809, 2083544, 1000391282, 8010478, 3005642384, 3043088937, 3043138885, 3027645317, 3003584784, 3010889707, 3008399755, 3006610913, 3043606682, 3004594181, 3015167933, 3010781643, 3038188821, 3002821232, 9615162
- FEI number
- 3021013124, 3014680809, 2083544, 1000391282, 3005642384, 3043088937, 3043138885, 3027645317, 3003584784, 3010889707, 3008399755, 3006610913, 3004063640, 3043606682, 3004594181, 3015167933, 3010781643, 3002179321, 3038188821, 3002821232
- K number
- K883514