This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

MULTIDIAGNOST ELEVA IMAGE DETECTORS (2016-07-13)

Starting date:
July 13, 2016
Posting date:
July 29, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59602

Affected products

  1. MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR
  2. MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR

Reason

Philips has become aware that the two bolts that attach the clamping plate to the lateral shaft may break. This may cause the c-arm to float freely. Depending on the orientation of the free-floating C-arm and any other forces applied to it the C-arm could move laterally forward, slide out of its bearings and then possibly sag.

Affected products

A. MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

0708MD02

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

B. MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

0708MD02

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