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Open, Classified

LUMINOS Lotus Max (VF11)

FDA Recall Z-1481-2023 · Posted 2023-05-23

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2022-11-23
Product Quantity704 units in the United States (1945 units worldwide)

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.

Firm 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

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide - Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173639Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. · 2018-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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