Health product recall

Maquet Surgical Lights

Brand(s)
Last updated

Summary

Product
Maquet Surgical Lights
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Volista Surgical Light All lots. ARDXXXXXXXXXX
Lucea 10/40 All lots. ARDXXXXXXXXXX
Lucea 50/100 All lots. ARDXXXXXXXXXX
PrismAlix All lots. ARDXXXXXXXXXX
Maquet Equipment All lots. ARDXXXXXXXXXX
Axcel+ All lots. ARDXXXXXXXXXX
Hanaulux HLX3000 All lots. ARDXXXXXXXXXX
Blueline Series 30/80 All lots. ARDXXXXXXXXXX
Power LED 300 Surgical Light All lots. ARDXXXXXXXXXX
Axcel All lots. ARDXXXXXXXXXX
H Led Surgical Light All lots. ARDXXXXXXXXXX
Blue Series 30/80 Surgical Light All lots. ARDXXXXXXXXXX
Maquet Power LED II All lots. ARDXXXXXXXXXX
Power LED Surgical Light All lots. ARDXXXXXXXXXX
X'Ten Surgical Light All lots. ARDXXXXXXXXXX

Issue

Maquet S.A.S. /Getinge has received a customer complaint regarding a fall of a light system in an operating room in Hong Kong (no injuries reported). Tnvestigation into this event demonstrated that the recommendation of maintenance and service were not performed as instructed in the current user and maintenance manuals. This notification communicates retrospectively current maintenance instructions and programs to customers.

Recall start date: November 29, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Maquet S.A.

Avenue De La Pomme De Pin, Orleans, France, 45074

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74719