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Open, Classified

Luminos Agile Max (VE10, VF10, VF11)

FDA Recall Z-1479-2023 · 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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

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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