Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 9/17/2014
Class lI:
PRODUCT
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Recall Number Z-2292-2014
REASON
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. This malfunction can only occur in automatic exposure mode. Moreover using this mode the malfunction will statistically only occur approximately once every 7000 images.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 7/7/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
192
DISTRIBUTION
Nationwide
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