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Siemens Medical Solutions USA, Inc recalls Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagn
Recalled September 17, 2014 · FDA recall Z-2292-2014 · Siemens Medical Solutions USA
Hazard
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. Thi · FDA Class II
Units
192
Sold at
Nationwide Distribution.
Description
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. Thi
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →