FDAFDA · Food and drugs·Recall number Z-1848-2013
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Published August 7, 2013 · Recall initiated: May 7, 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 became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Distribution including the states of CA, IN, NJ and OK.
- Lot
- Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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