Health product recall

MultiDiagnost Eleva - Image Intensifier - TV Image Detector and Flat Detector - Image Detector (2018-03-29)

Starting date:
March 29, 2018
Posting date:
April 24, 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-66542

Affected products

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

Reason

Philips has been reported instances in which the table of the Multidiagnost-Eleva (MD-Eleva) suddenly started to rotate from 0 to 90 degree (table arm down) with high speed. The cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. If the system rotates uncontrolled, there is a risk of injury for the patient on the table. A rotating table also might hit the user or bystander standing near the system.

Affected products

  1. MultiDiagnost Eleva - Image Intensifier - TV Image Detector

Lot or serial number

Not applicable

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

Not applicable

Model or catalog number

0708MD02

Companies
Manufacturer
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS