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Health product recall

S5 CORE IMAGING SYSTEMS(2015-07-11)

Starting date:
July 11, 2015
Posting date:
August 18, 2015
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-54694

Affected Products

  1. S5 Imaging System
  2. S5i/CORE/CORE Mobile imaging system

Reason

Certain testing sequences can cause an inaccurate calculation of the FFR/IFR value.

Affected products

A. S5 Imaging System

Lot or serial number

all lots. contact mfg

Model or catalog number
  • 400-0100.01
  • 400-0100.02
  • 804200-002
  • 804200-002-R
  • 804200-014
  • 806300-020
  • 807300-001
  • 807400-001
Companies
Manufacturer
Volcano Corporation,
2870 Kilgore Road,
Rancho Cordova
95670
California
UNITED STATES

B. S5i/CORE/CORE Mobile imaging system
 

Lot or serial number

all lots. contact mfg

Model or catalog number

400-0100.01
400-0100.02
804200-002
804200-002-R
804200-014
806300-020
807300-001
807400-001

Companies
Manufacturer
Volcano Corporation,
2870 Kilgore Road,
Rancho Cordova
95670
California
UNITED STATES

Date modified: