Device product
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Z-0086-2025
Product summary
- Event
- Event 95323
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-0086-2025
Official wording
Reason: As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
Code information: a) Material Number 1491510C002, UDI/DI (01)04049188002945, Serial Numbers: 5359022006, 5367012006, 5913, 5996, 5065, 5625022007, 5467072006, 5901, 5108122004, 5330, 5269, 5667; b) Material Number 1491510C003, UDI/DI (01)04049188002891. Serial Numbers: 5537
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.