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INTELLIVUE-INFORMATION CENTRE IX-SOFTWARE (2015-06-10)
- Starting date:
- June 10, 2015
- Posting date:
- July 9, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54156
Recalled Product
A. INTELLIVUE-INFORMATION CENTRE IX-SOFTWARE
Reason
It was determined that a Health Canada medical device licence amendment application was required on PIIC iX B.01 products shipping to Canada, because the operating system (OS) was changed from Windows 7 to Windows 8.1.
Affected products
A. INTELLIVUE-INFORMATION CENTRE IX-SOFTWARE
Lot or serial number
ALL
Model or catalog number
M3290B
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
Massachusetts
UNITED STATES