Z-1480-2023Class II

Luminos dRF Max (VE10, VF10, VF11)

Name: Z-1480-2023 Luminos dRF Max (VE10, VF10, VF11)
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-11-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-11-23 / Open, Classified

FDA source

Siemens Medical Solutions USA, Inc began a recall of Luminos dRF Max (VE10, VF10, VF11) on 2022-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1480-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-23
Posted: 2023-05-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Luminos dRF Max (VE10, VF10, VF11)
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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: Radiation Control for Health and Safety Act
Action: 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
Quantity in commerce: 704 units in the United States (1945 units worldwide)
Distribution: US Nationwide - Worldwide Distribution
Product codes and lots: Model: 10762471

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1480-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1479-2023	Class II	Ongoing	FDA Mandated	2023-05-31	2023-05-23
Z-1480-2023	Class II	Ongoing	FDA Mandated	2023-05-31	2023-05-23
Z-1481-2023	Class II	Ongoing	FDA Mandated	2023-05-31	2023-05-23

Product code OWB

K173639Class IILuminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. / cleared 2018-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)