Synapse Cardiovascular Image and Information & Viewing Management (2018-05-08)

Starting date:

May 8, 2018

Posting date:

October 26, 2018

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-68062

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  Reason
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  Affected products

Affected products

Synapse Cardiovascular Image and Information & Viewing Management

Reason

There is a malfunction in the system where inconsistent Mitral Valve Mean Pressure Gradient values are being reported. The values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis.

Affected products