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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
- S5 Imaging System
- 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