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INTELLIVUE-INFORMATION CENTER IX-SOFTWARE (2015-11-25)
- Starting date:
- November 25, 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-56304
Affected Products
INTELLIVUE-INFORMATION CENTER IX-SOFTWARE
Reason
A single reconstructed electrocardiogram (ECG) lead, printed or viewed at the Information Center IX System may be misrepresented in the presence of certain combinations of primary and secondary lead for analysis. These include Leads I and III, Leads III and AVF, and Leads I and AVR.
Following are the lead combinations that are affected:
- Lead I and Lead III are used to derive the AVL lead (incorrectly derived)
- Lead I and Lead AVR are used to derive the AVL lead (incorrectly derived)
- Lead I and Lead AVR are used to derive the AVL lead (incorrectly derived)
Affected products
LOGICIEL INTELLIVUE - INFORMATION CENTER IX
Lot or serial number
Not Applicable
Model or catalog number
M3290B
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES