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Recall Observatory FDA recall evidence

Device product

Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system

Z-0140-2014

September 03, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 66314
Status
Terminated
Classification
Class II
Quantity
59
Official record key
device-enforcement:Z-0140-2014

Official wording

Reason: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

Code information: Model numbers 10094910 and 10094200 with software version VD10A/G.

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software versions VD10A/G during a RAD examination, a malfunction