Health product recall

Philips OmniDiagnost and OmniDiagnost Eleva (2018-05-07)

Starting date:
May 7, 2018
Posting date:
May 18, 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-66816

Affected products

A. PHILIPS OMNIDIAGNOST

B. OMNIDIAGNOST ELEVA

Reason

Philips has been reported instances in which the table of the OmniDiagnost system (OD-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

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. 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