FDA-Device2014-09-17Class II
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.
Siemens Medical Solutions USA, Inc
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
Sold states
Nationwide Distribution.
Affected count
192
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2292-2014Don't want to check this manually?
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