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Luminos, uroskop and axiom systems

Official notice

24 Feb 2023

MediumHealth Canada

An official Health Canada notice concerns Luminos, uroskop and axiom systems. Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall cannot be ruled out during system movement. Siemens Healthineers has not become aware of any injuries caused by this issue. Recall start date: February 16, 2023 Published 2023-02-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72957

Official notice

2023-02-24

The hazard

Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall cannot be ruled out during system movement. Siemens Healthineers has not become aware of any injuries caused by this issue. Recall start date: February 16, 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

72957

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Affected products

Product 1

Affected products - Luminos Lotus Max, Lot or serial number - VF11C VF11G, Model or catalog number - 11574100

Product 2

Affected products - Luminos Agile, Lot or serial number - VC10Q, Model or catalog number - 10502200

Product 3

Affected products - Uroskop Omnia Max, Lot or serial number - VF11G VF10F VE10Z VF11C_HF01, Model or catalog number - 10762473

Product 4

Affected products - Axiom Luminos Drf, Lot or serial number - VD10U VD10T, Model or catalog number - 10094200

Product 5

Affected products - Luminos Drf Max, Lot or serial number - VF10F_HF03 VE10Y VF11C VF10F VF11E VF10C VF11C_HF01, Model or catalog number - 10762471

Product 6

Affected products - Luminos Agile Max, Lot or serial number - Not applicable, Model or catalog number - 10762472

Product 7

Affected products - Uroskop Omnia, Lot or serial number - VD10U VD10P, Model or catalog number - 10094910

Risk / hazard

Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall cannot be ruled out during system movement. Siemens Healthineers has not become aware of any injuries caused by this issue. Recall start date: February 16, 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: Siemens, Luminos Uroskop And Axiom.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72957

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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