Volista Surgical Lights (2018-05-24)

Starting date:

May 24, 2018

Posting date:

June 1, 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-66950

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  Reason
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  Affected products

Affected products

Volista Surgical Lights

Reason

It was established that, with some of the manufactured units, a screw has been forgotten on the bracket of the cupola on some devices in production or that the screws have loosened over the course of life. As a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. It appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation.

Affected products