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Recall Observatory FDA recall evidence

Device product

Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems

Z-0016-2014

May 06, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65161
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-0016-2014

Official wording

Reason: Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho

Code information: Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    malfunction when using system operating with software