VOLISTA Surgical Light (2019-04-30)

Starting date:

April 30, 2019

Posting date:

May 10, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69920

Last updated: 2019-05-10

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  Reason
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  Affected products

Affected Products

VOLISTA Surgical Light

Reason

Under certain conditions, Maquet have identified an issue that might prevent the device from performing as intended. Maquet SAS, the manufacturer, received some complaints regarding light head fork (yokes). It was established that the coating of those forks might show cracks. Therefore, there is a risk that particles may fall and generate an infection. Maquet SAS has not received any adverse event reports (i.e. infection) regarding this issue.

Affected products