LUMINOS Lotus Max (VF11) recallZ-1481-2023 · Siemens Medical Solutions USA, Inc · initiated Nov 23, 2022
Class II Open, Classified All recalls posted in May 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Siemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S
Recall details
- Recall number
- Z-1481-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2022
- Posted by the FDA
- May 23, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 704 units in the United States (1945 units worldwide)
- Product code
- OWB
- FDA submissions
- K173639
- Distribution
- US Nationwide - Worldwide Distribution
Product description
LUMINOS Lotus Max (VF11)
Code information (models, lots, serial numbers)
Model: 11574100
Other devices under the same FDA submission
2 devices cleared under K173639 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LUMINOS Lotus Max 11574100Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system2 recalls7 reports
- Multitom Rax 10860700Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92229).
- Z-1479-2023 · Open, ClassifiedLuminos Agile Max (VE10, VF10, VF11)
- Z-1480-2023 · Open, ClassifiedLuminos dRF Max (VE10, VF10, VF11)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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