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Maquet surgical lights

Official notice

7 Dec 2023

Last checked

7 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Maquet surgical lights. 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 Published 2023-12-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74719

Official notice

2023-12-07

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74719

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Affected products

Product 1

Affected products - Volista Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 2

Affected products - Lucea 10/40, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 3

Affected products - Lucea 50/100, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 4

Affected products - PrismAlix, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 5

Affected products - Maquet Equipment, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 6

Affected products - Axcel+, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 7

Affected products - Hanaulux HLX3000, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 8

Affected products - Blueline Series 30/80, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 9

Affected products - Power LED 300 Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 10

Affected products - Axcel, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 11

Affected products - H Led Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 12

Affected products - Blue Series 30/80 Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 13

Affected products - Maquet Power LED II, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 14

Affected products - Power LED Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Product 15

Affected products - X'Ten Surgical Light, Lot or serial number - All lots., Model or catalog number - ARDXXXXXXXXXX

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Maquet S.a, Maquet Surgical Lights.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74719

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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