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Health product recall

Multidiagnost Eleva - Image Intensifier - TV Image Detector and Multidiagnost Eleva - Flat Detector - Image Detector (2015-01-20)

Starting date:
January 20, 2015
Posting date:
January 28, 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-43473

Recalled products

  1. Multidiagnost Eleva - Image Intensifier - TV Image Detector
  2. Multidiagnost Eleva - Flat Detector - Image Detector

Reason

Philips Healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect. In the MD Eleva system, software license keys are used to enable particular functionality. In software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded:

  • the license key for spectral filter
  • the license key for full table tilt range

Affected products

A. Multidiagnost Eleva - Image Intensifier - TV Image Detector

Lot or serial number

All lots

Model or catalog number
  • 0708MD02
Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS

B. Multidiagnost Eleva - Flat Detector - Image Detector

Lot or serial number

All lots

Model or catalog number
  • 0708MD02
Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS