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Health product recall

Intellivue Information centre IX - software (2015-04-13)

Starting date:
April 13, 2015
Posting date:
May 8, 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-53277

Recalled Products

A. Intellivue Information centre IX - software

Reason

Philips has become aware that when HL7 lab messages are sent to a PIIC iX system that has been localized for comma delimiters, the lab result is incorrectly displayed on the bedside monitor. An expected delimiter is stripped from the lab value and the number shown is of a higher magnitude than expected. If lab results are incorrect, a clinician may initiate incorrect treatment or delay necessary treatment this problem only happens when the PIIC iX is configured during set up for regional settings where the delimiter is a comma. The lab option must be in use, and the workflow utilizes the automatic lab interface displayed at the bedside monitor.

Affected products

A. Intellivue Information centre IX - software

Lot or serial number

1M4H-34MB-4
4744-35J4-F
577U-56K0-9
5G4L-1CJJ-0
7U00-2CJW-V
7Z4V-37N1-L

Model or catalog number

M3290B

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
Massachusetts
UNITED STATES