LEICA BIOSYSTEMS NUSSLOCH GMBH: Medical Device Recall in 2025 - (Recall #: Z-1247-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 30, 2025

Date Posted: March 5, 2025

Recall Number: Z-1247-2025

Event ID: 96220

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2

Code Information:

Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

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.

Voluntary or Mandated:

Voluntary: Firm initiated