Leica Cryostats (2019-03-18)

Starting date:

March 18, 2019

Posting date:

April 12, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69560

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

Leica Cryostats

Reason

During post market surveillance, it was realized that some customers are using flammable freezing sprays within the Cryostat chamber. Such flammable freezing sprays can potentially ignite and can cause serious injuries.  The current device labeling does not include any specific warning about the usage of flammable freezing sprays, therefore the corrective action will improve the device labeling with an adhesive warning label and safety amendment to the instrument instruction for use (IFU).

Affected products