Luminos, Uroskop and Axiom Systems
Brand(s)
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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