Health product recall

MultiDiagnost-ELEVA, OmniDiagnost Systems (2019-03-03)

Starting date:
March 3, 2019
Posting date:
March 15, 2019
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-69314

Affected Products

  1. Philips OmniDiagnost
  2. MultiDiagnost-ELEVA Intensifier - TV Image Dectector
  3. MultiDiagnost-ELEVA - Flat Detector - Image Detector
  4. MultiDiagnost-ELEVA - System
  5. OmniDiagnost ELEVA

Reason

For the height and tilt movement of the stand/table, the MultiDiagnost-ELEVA, OroDiagnost and OmniDiagnost systems have 2 actuators that are connected to the system stand by 4 shafts. The position of each of these shafts is secured by a locking plate.

During service of two MultiDiagnost-ELEVA systems, it was noticed that a locking plate was missing. In one of these cases, the shaft was still properly positioned after the system had been in use for 9 years. In the other case, involving a system that had been in use for 5 years, the shaft was no longer properly positioned but was still holding the actuator.

Over time, a missing locking plate may result in the shaft of the corresponding connection point becoming improperly positioned. If the shaft works its way totally out of position, it could result in unexpected stand/table tilt movement that cannot be stopped by the user.

Affected products

A. Philips OmniDiagnost

Lot or serial number

Not applicable.

Model or catalog number

OMNIDIAGNOST

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


B. MultiDiagnost-ELEVA Intensifier - TV Image Dectector

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


C. 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


D. MultiDiagnost-ELEVA - System

Lot or serial number

Not applicable.

Model or catalog number

MRC 3011

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS


E. OmniDiagnost ELEVA

Lot or serial number

Not applicable.

Model or catalog number

708027

Companies
Manufacturer

Philips Medical Systems Nederland B.V.

Veenpluis 4-6

Best

5684 PC

NETHERLANDS