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

FDA device recall Z-1247-2025 · posted 2025-02-27 · Open, Classified

Recall details

Recalling firm

LEICA BIOSYSTEMS NUSSLOCH GMBH

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

IDP

Quantity affected

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, P

Date initiated

2025-01-30

Date posted

2025-02-27

Location

Nussloch, Germany