Luminos dRF Max (VE10, VF10, VF11)
FDA device recall Z-1480-2023 · posted 2023-05-23 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 704 units in the United States (1945 units worldwide)
- Distribution
- US Nationwide - Worldwide Distribution
- Date initiated
- 2022-11-23
- Date posted
- 2023-05-23
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (K173639) | Siemens Medi Cal Solutions, Inc. | 2018-04-02 |