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Health product recall

Multidiagnost Eleva-Image Intensifier and Multidiagnost Eleva-Flat Detector

Starting date:
January 11, 2012
Posting date:
January 23, 2012
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-26263

Recalled Products

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

Reason

Due to an incorrect algorithm, the Air Kerma (AK) and Air Kerma Rate Values are not displayed correctly. The displayed AK is using an incorrect point of reference. This is a non-compliance per the Radiation Emitting Devices Act (R.S.C., 1985, section 6).

Affected products

A. Multidiagnost Eleva-Image Intensifier – TV Image Detector

Lot or serial number
  • N/A
Model or catalog number
  • 0708MD02
Companies
Manufacturer
Philips Medical Systems Nederland B.V.

B. Multidiagnost Eleva-Flat Detector – Image Detector

Lot or serial number
  • N/A
Model or catalog number
  • 0708MD02
Companies
Manufacturer
Philips Medical Systems Nederland B.V.