Health product recall

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

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

Synapse Cardiovascular Image and Information & Viewing Management

Lot or serial number

All lots.

Model or catalog number

SYNAPSE CARDIOVASCULAR CLIENT SOFTWARE

Companies
Manufacturer
Fujifilm Medical Systems USA
3020 Carrington Mill Blvd
Morrisville
27560
North Carolina
UNITED STATES