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Volcano s5 and CORE Series (2016-04-29)
- Starting date:
- April 29, 2016
- Posting date:
- June 30, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-59108
Affected products
A. Volcano s5 Series- s5x,s5ix/s5iz
B. CORE Series- CORE Mobile, CORE
Reason
Volcano corporation is initiating a voluntary field corrective action because an issue has been identified with sofware versions v3.2.x, v3.3, and v3.4 that runs on the s5/s5i/CORE/CORE mobile systems ("impacted systems"). This voluntary recall only affects impacted systems. Volcano corporation has become aware of a system incompatibility issue between impacted systems and hospital network scans.
Affected products
A. Volcano s5 Series- s5x,s5ix/s5iz
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
804200-001
807300-001
Companies
- Manufacturer
-
Volcano Corporation
2870 Kilgore Road
Rancho Cordova
95670
UNITED STATES
B. CORE Series- CORE Mobile, CORE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
806300-001
807400-001
807400-001-R
Companies
- Manufacturer
-
Volcano Corporation
2870 Kilgore Road
Rancho Cordova
95670
UNITED STATES