Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 11/13/2013
Class lI:
PRODUCT
Siemens RAD Fluoro Uro Systems – Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Recall Number Z-0016-2014
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; however, there are emergency circuits active which will stop radiation through another independent mechanism. If the image quality of the overexposed image is unacceptable for diagnosis, the examination could potentially have to be repeated. The upgrade to software version VB10G resolves this potential malfunction. For patients who were treated with affected systems in the past, no measures such as additional treatment or aftercare are necessary.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 5/6/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
23
DISTRIBUTION
Nationwide
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