Siemens Medical Solutions USA, Inc Luminos dRF Max (VE10, VF10, VF11) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Luminos dRF Max (VE10, VF10, VF11)
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model: 10762471
Products Sold
Model: 10762471
Siemens Medical Solutions USA, Inc is recalling Luminos dRF Max (VE10, VF10, VF11) due to Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026