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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Leica Biosystems CM1950 Cryostats Recalled for Software Issue

Agency Publication Date: February 27, 2025
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Summary

Leica Biosystems has recalled two CM1950 Cryostats (model 1491950C4US) equipped with firmware version 3.01 due to a software defect. The company identified that the most recent firmware update could cause a failure that results in the loss of patient tissue samples. While no incidents or injuries have been reported, the manufacturer is taking action to prevent potential diagnostic delays or the need for repeat patient biopsies.

Risk

A software error in the cryostat's firmware can malfunction during use, potentially leading to the irreversible loss or destruction of patient tissue specimens. This creates a risk where medical professionals may be unable to complete a diagnosis, necessitating additional invasive procedures for the patient.

What You Should Do

  1. This recall affects Leica Biosystems CM1950 Cryostats, model 1491950C4US, specifically units with serial numbers 12835 and 12854 running firmware version 3.01.
  2. Stop using the recalled cryostats immediately to prevent potential loss of patient tissue samples.
  3. Contact Leica Biosystems or your authorized distributor to arrange for a firmware correction, replacement, or further technical instructions.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Leica Biosystems CM1950 Cryostats
Model / REF:
1491950C4US
Serial Numbers:
12835
12854
UDI:
(01)04049188139030

Affected units are running firmware version 3.01.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96220
Status: Active
Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH
Sold By: Leica Biosystems
Manufactured In: Germany
Units Affected: 2
Distributed To: Idaho, Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.