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