Leica Biosystems CM1950 Cryostats: Risk of Patient Tissue Loss After Firmware Update

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Contact the company & request your remedy

Recalling firmLEICA BIOSYSTEMS NUSSLOCH GMBHHeidelberger Str. 17-19, N/A · Nussloch, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Leica Biosystems is recalling CM1950 cryostats with firmware version V3.01 (model : 1491950C4US) because software issues could cause loss of patient tissue. This affects specific units with known serial numbers and model numbers.

Why it’s dangerous

Software issues in the most recent firmware update could lead to loss of patient tissue during use. This is a potential risk that may affect the accuracy or safety of tissue samples.

Who’s affected

Users of Leica Biosystems CM1950 cryostats with firmware version V3.01 (model 1491950C4US) and specific serial numbers are affected. Medical facilities using these units are most at risk.

How to tell if you have this one

Check for the model number 1491950C4US and firmware version V3.01 on your CM1950 cryostat. Affected units have specific serial numbers: 12835 and 12854.

Brand
Leica Biosystems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Firmware Version
Verify your cryostat's firmware version by checking the model number and serial number on the device.

✎ GovInfoNow

Questions people ask

What firmware version is affected?

Firmware version V3.01 is affected for model 1491950C4US.

Which serial numbers are affected?

Serial numbers 12835 and 12854 are affected.

Do I need to stop using my cryostat?

The recall does not specify a stop-use action; check firmware version to determine if your unit is affected.

Take action

Contact Leica Biosystems

We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1247-2025 — Leica Biosystems Leica Biosystems

Hello,

I own a Leica Biosystems that is covered by recall Z-1247-2025 from Leica Biosystems.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1247-2025 (January 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1247-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Lower-risk recall