Volista Surgical Lights (2018-01-08)

Starting date:

January 8, 2018

Posting date:

January 29, 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-65780

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  Reason
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  Affected products

Affected products

Volista Surgical Lights

Reason

There is a possibility that the central handle holder detaches from the cupola during use. We determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring. There is a remote chance that this issue may cause post-operative infection, foreign body granuloma or allergic reactions, if the particles fall into the patient's wound or on sterile equipment.

Affected products