Product Wiki · Recalls · Health Canada — Medical Devices

VOLISTA Surgical Light (2019-04-30) — recall 59110

Health Canada — Medical Devices · Canada · 2019-05-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59110
Date of alert
2019-05-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/volista-surgical-light-2019-04

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