FDAFDA · Food and drugs·Recall number Z-1097-2013
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
Published April 17, 2013 · Recall initiated: January 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA.
- Lot
- Model Number 5902767 with serial numbers 2217, 2038, 1228, 1007, 1219, 2156, 2264, 2190, 2132, 2213, 1484, 2166, 2259, 2068, 1610, 1601, 1413, 2236, 2153, 1444, 1477, 1632, 2037, 2180, 1663, and 1612; Model Number 5902783 with serial numbers 1003, 1401, 1402, and 1405; Model Number 7152478 with serial numbers 2580, 2524, 2590, 2536, 2563, and 2534; Model Number 10093962 with serial numbers 5837, 5120, 5523, 5910, 5507, 6141, 4112, 6274, 4506, 5900, 4121, 6245, 6242, 4509, and 6113.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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