Recall Z-1480-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Luminos dRF Max (VE10, VF10, VF11)
| Date | May 23, 2023 (initiated Nov 23, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| 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 | 704 units in the United States (1945 units worldwide) |
| Distribution | US Nationwide - Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |