Health product recall

Luminos, Uroskop and Axiom Systems

Last updated

Summary

Product
Luminos, Uroskop and Axiom Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or serial number

Model or catalog number

Luminos Lotus Max

VF11C
VF11G

11574100

Luminos Agile

VC10Q

10502200

Uroskop Omnia Max

VF11G
VF10F
VE10Z
VF11C_HF01

10762473

Axiom Luminos Drf

VD10U
VD10T

10094200

Luminos Drf Max

VF10F_HF03
VE10Y
VF11C
VF10F
VF11E
VF10C
VF11C_HF01

10762471

Luminos Agile Max

Not applicable

10762472

Uroskop Omnia

VD10U
VD10P

10094910

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Siemens Healthcare GmbH

Henkestr. 127, Erlangen, Germany, 91052

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72957

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