Health product recall

IntelliVue Information CenteriX - Software (2018-01-08)

Starting date:
January 8, 2018
Posting date:
January 29, 2018
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-65816

Affected products

IntelliVue Information CenteriX - Software

Reason

Philips has become aware of an issue affects all PIIC iX Surveillance and Patient Link revisions. The issue will occur after a surveillance station is first restarted during the year 2018. After that initial restart, the station will thereafter no longer perform patient Discharge and Transfer operations. Subsequent application restarts will occur when any of the following operations are performed:

  • Discharging a patient under certain conditions
  • Transferring a patient (from bedside or central station)
  • Resolving patient conflicts (from bedside or central station) where bedside’s patient must overwrite PIIC iX’s patient (revision B.0x and C.0x only)
  • Clearing a surveillance sector
  • Assigning a bed to an empty surveillance sector

The surveillance station will continue to monitor patients after any restart.

Affected products

IntelliVue Information CenteriX - Software

Lot or serial number

Not applicable

Model or catalog number

M3290B

Companies
Manufacturer

Philips Medical Systems

3000 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES