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FDA (Device enforcement)Recalled 2025-01-30class ii

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

Hazard

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

Details from the source

Reason for recall: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. 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, Poland, Singapore. Quantity: 2 Lot/code info: Model No: 1491950C4US UDI-DI: (01)04049188139030 Serial Numbers 12835, 12854

UPC codes

04049188139030

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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