LEICA BIOSYSTEMS NUSSLOCH GMBH: Device Recall

Recall Details

Recall Number

Z-1247-2025

Classification

Class II

Product Type

Device

Recalling Firm

LEICA BIOSYSTEMS NUSSLOCH GMBH

Status

Ongoing

Date Initiated

01/30/2025

Location

Nussloch, N/A, Germany

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2

Reason for Recall

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.

Product Description

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

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.

Other Recalls by LEICA BIOSYSTEMS NUSSLOCH GMBH

• Class II: Risk 09/04/2024
  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.
• Class II: Risk 09/04/2024
  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.
• Class II: Risk 09/04/2024
  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.
• Class II: Risk 09/04/2024
  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.
• Class II: Risk 09/04/2024
  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.

View all recalls by LEICA BIOSYSTEMS NUSSLOCH GMBH →